Iron (ferrous sulfate vs bisglycinate vs other forms) trials recruiting now

Who the trial lists, as registered

Lists people 2 to 17. Conditions: Chronic Kidney Disease; Iron Deficiency Anemia.

• Male or female 2 years to <18 years of age at time of consent
• Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2…
• Has Chronic Kidney Disease defined as one of the following:
• on chronic hemodialysis;

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Ferumoxytol; Iron sucrose

Registered summary

Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

Where, as registered

8 US sites in 6 states; also Mexico (4), Poland (4), Lithuania (3), Hungary (2).

Who the trial lists, as registered

Lists people 2 to 17. Conditions: Iron Deficiency Anemia.

• Male or female 2 years to <18 years of age at time of consent
• Has IDA defined as:
• Hemoglobin (Hgb) <11.0 g/dL AND
• Any one or more of the following:

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

ferumoxytol; Iron sucrose

Registered summary

This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).

Where, as registered

6 US sites in 4 states; also Poland (6), Lithuania (3).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Allogeneic Stem Cell Transplant.

• Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
• Age ≥18 years
• Karnofsky performance status >70%, see Appendix A
• Patients must be able to swallow capsules/tablets

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Iron chelation; Potato Resistant Starch

Registered summary

The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Cardiac Surgery.

• ICU hospitalized patients who underwent non-emergent cardiac surgery
• Post operative iron deficient or anemic patients (Hb< 12 for both men and women).
• Patients following the same pre-operative protocol
• Age >18 years

The exclusion criteria are on the listing.

What it tests, as registered

Sucrosomial Iron (SI)

Registered summary

Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments. Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older; healthy volunteers accepted. Conditions: Iron Deficiencies.

• Provide voluntary, written, informed consent to participate in the study
• Agree to provide a valid cell phone number and are willing to receive communications through text
• Can read and write English
• Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Qualia Iron Version A; Qualia Iron Version B; Placebo

Registered summary

This double-blind parallel pilot study will evaluate the safety and efficacy of two Qualia Iron formulations versus placebo in approximately 40 healthy adults (aged 18+) over a 56-day period. Approximately 40 participants will be assigned to three study arms: Qualia Iron Version 1, 2, (n=15 each) or a Placebo (n=10). Each participant will take one or two capsules once daily in the morning, with or without food. The supplementation regimen is a 5 days on, 2 days off protocol, and goes for 56 days (8 weeks). The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 18 to 45; healthy volunteers accepted. Conditions: Iron Deficiencies; Low Ferritin; Iron Deficiency; Exercise Performance of Fit Athletes.

• Women, 18 - 45 years of age
• No changes in hormonal contraception use in the past 6 months
• Has a regular menstrual cycle defined as five out of the past six months
• Engaging in ≥5 hours per week of structured endurance exercise (e.g., running, cycling, swimming, rowing) for the past ≥6 months, with ≥3 sessions per week at moderate-to-vigorous intensity (≥70% HRmax or RPE ≥13).

14 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Lactoferrin 100 mg; Lactoferrin 300 mg; Iron Supplementation (5 mg)

Registered summary

This randomized, double-blind, active-controlled trial will evaluate the effects of human lactoferrin supplementation combined with low-dose iron on iron status, aerobic performance, and lactate metabolism in exercising women with low ferritin. Approximately 30 healthy, menstruating women aged 18-45 years with serum ferritin \<35 µg/L will be enrolled in an 8-week intervention. Participants will be stratified by baseline ferritin status and randomized to receive 100 mg lactoferrin + 5 mg iron, 300 mg lactoferrin + 5 mg iron, or placebo + 5 mg iron daily. The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 15 to 49; healthy volunteers accepted. Conditions: Birth Weight.

• For the primary outcome, mothers who deliver a liveborn child in enrolled health facilities and who are willing/consent to participate in the study.
• For the secondary objectives, all antenatal care staff and women attending for routine antenatal care during the survey periods will be included.

The exclusion criteria are on the listing.

What it tests, as registered

Multiple micronutrient supplementation (MMS); Iron folate supplementation (IFA)

Registered summary

Background: This programme effectiveness study responds to the need for evidence on the effect on birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. A 2019 meta-analysis of trial data reported a mean improvement of 35g in newborn birthweight amongst newborns born to women who took MMS in pregnancy compared to those who took IFA. The full summary is on the listing.

Where, as registered

No US site; Ethiopia (6).

Who the trial lists, as registered

Lists people of any age. Conditions: Stunting; Gender Equality; Acceptability of Health Care; Diet; Deficiency; Empowerment.

• 15-49 y of age
• biological mother of child in the home who is 0-5.9, 6-23.9, or 24-59.9 months
• has lived in the community for at 12 months (ii) Husbands/partners:
• no age limit

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights; school-based iron-folic acid supplement program; Health service training on equitable access to nutrition, health, and sexual and reproductive services; bio-fortified crops

Registered summary

This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention communities, schools, and health facilities. Only baseline and endline will be collected on the comparison communities. The full summary is on the listing.

Where, as registered

No US site; Bangladesh (1), Kenya (1), Tanzania (1).

Who the trial lists, as registered

Lists female participants 18 and older; healthy volunteers accepted. Conditions: Pregnancy Related.

• Attending first ANC visit at study clinics
• Pregnant women < 20 weeks gestation by last menstrual period (LMP)
• Aged ≥ 18 years old
• Intending to stay in Dar es Salaam until 6 weeks post delivery

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Multiple Micronutrient Supplements with 30 mg of elemental iron; Multiple Micronutrient Supplements with 45 mg of elemental iron; Multiple Micronutrient Supplements with 60 mg of elemental iron

Registered summary

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.

Where, as registered

No US site; Tanzania (1).

Who the trial lists, as registered

Lists female participants 10 to 18; healthy volunteers accepted. Conditions: Neurodevelopment Outcome; Linear Growth; Micronutrient Status; Bone Mineral Density; Underweight; Stunting; Body Composition; Blood Pressure; HRQOL (Health Related Quality Of Life); Waist-to-height Ratio.

• Unmarried 10-18 year old females
• living in their parental home in the study area

The exclusion criteria are on the listing.

What it tests, as registered

Iron (60 mg)- folic acid (400 ug) [IFA]; Multiple micronutrient supplement [MMS]; Multiple micronutrient supplement Plus [MMS+]

Registered summary

MEDHA is a randomized controlled trial among 10-18 year old girls to examine the use-case of the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) multiple micronutrient supplement (MMS) formulation and to test an enhanced regimen (MMS+) with additional nutrients, vs. weekly iron-folic acid as standard of care on outcomes of neurodevelopment, linear growth, biochemical status, bone health, and other functional and health outcomes. The full summary is on the listing.

Where, as registered

No US site; Bangladesh (1).

Who the trial lists, as registered

Lists female participants 18 to 35. Conditions: Anemia.

• Pregnant women aged 18 to 35 years.
• Gestational age between 13 and 26 completed weeks, confirmed by last menstrual period and/or early ultrasound dating.
• Diagnosed with moderate to severe iron deficiency anemia (IDA), defined as:
• Singleton intrauterine pregnancy confirmed by ultrasonography.

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Ferric citrate 210 mg; Ferrous fumarate 200 mg

Registered summary

Maternal anemia remains a significant public health concern in low and middle income countries including Bangladesh, contributing to adverse maternal and neonatal outcomes. Despite the widespread use of oral ferrous fumarate, gastrointestinal intolerance and suboptimal adherence remain persistent challenges, indicating the need for alternative iron formulations with improved efficacy and safety profiles. The full summary is on the listing.

Where, as registered

No US site; Bangladesh (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Anemia; Anemia, Iron-Deficiency; Iron Deficiency Anemia Treatment; Iron Deficiency Anemia (IDA); Cardiac Surgical Patients; Blood Loss, Surgical.

What it tests, as registered

Iron

Registered summary

The ICARUS 2 study has the general objective of collecting data in patients undergoing cardiac surgery; in our centre, in order to optimize and improve hemoglobin values, a team of haematologists, assisted by cardio anesthetists and cardiac surgeons, will evaluate the blood tests of patients scheduled for elective cardiac surgery in order to correct any states of hypoferritinemia (low iron in the blood) to promote recovery from blood losses related to cardiac surgery. This objective is strongly encouraged by the good use of blood programs currently in force at our foundation. The full summary is on the listing.

Where, as registered

No US site; Italy (1).

Who the trial lists, as registered

Lists female participants 18 and older; healthy volunteers accepted. Conditions: Iron Deficiency Anemia of Pregnancy.

• Age ≥ 18 years
• BMI ≥18.5 kg/m2
• Without current pregnancy complications (for example, severe bleeding, Diabetes Mellitus, hyperemesis gravidarum, ectopic and molar pregnancies)
• At least 12 Gestational Week

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Adiposity and Iron Requirements in Pregnancy (ADIPREG)

Registered summary

This study aims to explore how body fat influences the response to either 25 or 50 mg of daily iron supplements during pregnancy. We will conduct a double-blind randomized controlled intervention study involving 312 pregnant women recruited from antenatal clinics in the Northern Trust Area. Participants will be randomly assigned to receive either 25 or 50 mg of iron per day from 12 weeks of pregnancy until delivery, using the Active Iron supplement brand. Blood samples will be collected at 12, 28 and 36 weeks gestation and umbilical cord blood will be collected at delivery. The full summary is on the listing.

Where, as registered

No US site; United Kingdom (3).

Who the trial lists, as registered

Lists female participants 18 to 50; healthy volunteers accepted. Conditions: Iron Deficiency Anaemia in Childbirth.

• 18 years of age and over
• Pregnancy with Gestational age ≥13 weeks
• Iron deficiency anemia defined as:
• Hemoglobin less than or equal to 110g/L and

6 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Iron Isomaltoside 1000, ferric derisomaltose; Iron sucrose

Registered summary

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. The full summary is on the listing.

Where, as registered

No US site; Canada (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Anemia; Sepsis; Septic Shock.

• age ≥18,
• diagnosed sepsis (Sepsis-3) or septic shock (Septic Shock-3),
• hemoglobin <120 g/L in both sexes.

The exclusion criteria are on the listing.

What it tests, as registered

Iron; EPO; 0.9 % NaCl

Registered summary

Background Up to 66% of have anemia at the admission to the intensive care unit. This number increases to 95% after 72 hours of hospitalization in the intensive care unit due to illness and iatrogenic blood loss. Anemia worsens tissue oxygenation, especially in patietns with sepsis or septic shock, who already have blood flow issues. Instead of giving blood transfusions, which can have side effects, we aim to address the root causes of anemia in these patients. Sepsis can cause "inflammatory anemia" and combine with iron deficiency anemia. The full summary is on the listing.

Where, as registered

No US site; Poland (1).

Who the trial lists, as registered

Lists people 6 months to 5; healthy volunteers accepted. Conditions: Iron Deficiency Anemia; Iron Deficiency, Anaemia in Children.

• Patients having iron deficiency anemia

The exclusion criteria are on the listing.

What it tests, as registered

Ferrous sulfate; Iron Polymaltose Complex

Registered summary

This study aims to compare the efficacy of two iron preparation for the management of children presented with iron deficiency anemia. Ferrous sulphate and lron polymaltose (ferric form) are most commonly used preparations. Both drugs are easily available in market and are often recommended by pediatriclans. The efficacy, bioavail.tbilily, side effects and cost of these preparations vary. This study is designed to find out a drug with better efficacy that can be used for treatment of iron deficiency anemia in local population.

Where, as registered

No US site; Pakistan (1).

Who the trial lists, as registered

Lists people 0 to 18. Conditions: Varus-Derotation Osteotomy Surgery; Iron-deficiency Anemia; Pelvic Osteotomy Surgery; Cerebral Palsy.

• All patients scheduled for VDRO and/or pelvic osteotomy surgery (prospective cohort)
• All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 (historical cohort)
• Ages 0-18 years old

The exclusion criteria are on the listing.

What it tests, as registered

Iron Supplement; Comprehensive Nutrition Management

Registered summary

Varus-derotation osteotomy (VDRO) is a surgery to prevent or address hip displacement in children. Many children having this surgery have cerebral palsy or other neuromotor disorders, who have a higher rate of malnutrition, including low iron or anemia. This can affect their surgical outcomes, such as increasing their need for blood transfusions. This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions. This may include taking iron supplementation for patient with low iron or anemia. The full summary is on the listing.

Where, as registered

No US site; Canada (1).

Who the trial lists, as registered

Lists female participants 19 to 42; healthy volunteers accepted. Conditions: Pregnancy; Iron Deficiency.

• Pregnant individual (singleton pregnancy)
• 19-42 years of age
• Living in the greater Vancouver area and willing to travel to the University of British Columbia or BC Women's Hospital for study visits
• 13-25 weeks gestation

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Ferrous fumarate; Ferrous bisglycinate

Registered summary

This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. The full summary is on the listing.

Where, as registered

No US site; Canada (2).

Who the trial lists, as registered

Lists people 14 days to 14 days; healthy volunteers accepted. Conditions: Premature Birth.

• Premature babies between 28 0/7WA and 34 6/7 WA
• Parental consent, postnatal
• Age of 2 weeks

The exclusion criteria are on the listing.

What it tests, as registered

Iron Supplement

Registered summary

BienFer is a double-blinded randomized controlled trial about iron substitution and abdominal pain. Premature babies and low birth weight babies have lower iron stores than term newborns and are therefore at greater risk of iron deficiency and anemia. Iron deficiency could have consequences for cerebral development. Ferric substitution reduces the risk of iron deficiency and anemia. It is common to replace premature babies with iron substitution between 2 weeks and 6 months of life. In practice, the medical staff notice that newborn with iron substitution have abdominal pain and constipation. The full summary is on the listing.

Where, as registered

No US site; Switzerland (2).

Who the trial lists, as registered

Lists female participants 18 and older. Conditions: Anemia; Iron Deficiency Anemia (IDA).

• Female participants ≥ 18 years
• Mild anemia (11.0 ≤ Hb < 12 g/dL) or moderate anemia (8.0 < Hb < 11 g/dL)
• Signed informed consent

The exclusion criteria are on the listing.

What it tests, as registered

Sucrosomial® Iron (Sideral® Forte); Ferric Maltol (Feraccru®)

Registered summary

This study aims to compare two oral iron treatments, Sucrosomial® Iron and Ferric Maltol, in women with mild to moderate iron deficiency anemia. Many patients experience gastrointestinal side effects or poor tolerability with traditional iron supplements, which may limit adherence. Participants will be randomly assigned to receive either Sucrosomial® Iron or Ferric Maltol for 12 weeks. The primary objective is to determine whether Sucrosomial® Iron is as effective as Ferric Maltol in normalizing hemoglobin levels.

Where, as registered

No US site; Spain (7).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Patient Blood Management; Cardiac Surgery; Iron Deficiency Anemia.

• Age 18 years and above
• Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L
• Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)
• ASA: Grade 1-3

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Iron Sucrose, recombinant human erythropoietin, ascorbic acid; conventional treatment

Registered summary

We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. The full summary is on the listing.

Where, as registered

No US site; China (1).

Who the trial lists, as registered

Lists female participants 18 to 45. Conditions: Overweight and Obese Women.

• BMI ≥ 27.5 kg/m2
• serum ferritin <30 μg/L
• hemoglobin ≥ 11 g/dl
• fasting blood glucose < 5.6 mmol/L

The exclusion criteria are on the listing.

What it tests, as registered

195 mg iron daily; 15 mg iron daily

Registered summary

The study will be a randomized, double-blind, 17-day metabolic intervention trial including 14 days of high-dose or low-dose iron supplementation. A total of 70 overweight or obese (OW/OB) women will be enrolled. Participants will be individually randomized into either the high-iron or low-iron group. Women in the low-iron group will receive 15 mg of iron as ferrous fumarate daily for 14 days, while women in the high-iron group will receive 195 mg of iron as ferrous sulfate daily for 14 days. The study consists of three visits in total. The full summary is on the listing.

Where, as registered

No US site; Lebanon (1).

Who the trial lists, as registered

Lists people 12 months to 54 months; healthy volunteers accepted. Conditions: Iron Absorption; Iron Deficiencies; Severly Acutely Malnourished Children; Malnutrition in Children; Anemia.

• severe acute malnutrition (SAM): WHZ < -3.0
• moderate acute malnutrition (MAM): WHZ < -2.0 a
• treated as outpatients (no acute medical conditions and a positive appetite test) healthy children:

The exclusion criteria are on the listing.

What it tests, as registered

Iron absorption from RUTF on Day 0; Treatment with RUTF for 80 days; Iron absorption from RUTF on Day 20; Iron absorption from RUTF on Day 40; Iron absorption from RUTF on Day 60

Registered summary

Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. The full summary is on the listing.

Where, as registered

No US site; Kenya (1), Switzerland (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Chronic Heart Failure; Iron-deficiency; Left Ventricular Systolic Dysfunction.

• Chronic HF (New York Heart Association \[NYHA\] functional class II-IV) patients, on optimal therapy, and clinically stable for at least 4 weeks with no dose changes of HF drugs
• LVEF<50% at screening visit (historical value can be used if performed within 6 months of screening visit)
• Either a documented hospitalization for HF in the previous 12 months of enrolment or an elevated NT-proBNP: ≥250 pg/mL (or BNP ≥75 pg/mL) for patients in normal sinus rhythm; ≥1,000 pg/mL (or BNP ≥400 pg/mL) for patients in atrial…
• TSAT <20%

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Sucrosomial iron; Placebo

Registered summary

The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID). The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo. One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.

Where, as registered

No US site; Italy (1).

Who the trial lists, as registered

Lists people 20 and older. Conditions: Iron Deficiency Anemia Treatment.

• Male or female patients aged ≥20 years diagnosed with iron deficiency anemia, defined as: hemoglobin (Hb) <13 g/dL in males or <12 g/dL in females, and ferritin <50 ng/mL or transferrin saturation (TSAT) <20%.
• No iron supplementation within the past 3 months.

The exclusion criteria are on the listing.

What it tests, as registered

Ferrous Fumarate Oral Tablet

Registered summary

The goal of this clinical trial is to compare the effectiveness and tolerability of two different oral iron regimens in adults with iron deficiency anemia (IDA). The main questions it aims to answer are: Is alternate-day oral iron supplementation as effective as once-daily dosing in improving hemoglobin levels? What are the side effects associated with each dosing regimen? Researchers will compare once-daily vs. alternate-day oral ferrous fumarate to evaluate whether alternate-day dosing is non-inferior in terms of hematologic response, with fewer adverse effects. The full summary is on the listing.

Where, as registered

No US site; Thailand (1).

Who the trial lists, as registered

Lists female participants 18 to 35. Conditions: Pregnancy.

• female
• pregnant at gestational age 12 (±1) weeks (dated by ultrasound)
• age 18 to 35 y
• Hb concentration ≥80 g/L

5 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

MMS with 30 mg iron; MMS with 60 mg iron; IFA with 60 mg iron

Registered summary

This study evaluates iron absorption from three antenatal supplements, 30 mg MMS, 60 mg MMS, and 60 mg IFA, in 50 pregnant Kenyan women in their second trimester. Using a randomized crossover design and stable iron isotopes, we will compare bioavailability in both fasted and fed states. Additionally, the trial will investigate if daily dosing triggers a hepcidin response that inhibits subsequent absorption, testing whether alternate-day dosing is a more effective strategy for treating iron deficiency.

Where, as registered

No US site; Kenya (2).

Who the trial lists, as registered

Lists female participants 18 to 45. Conditions: Iron Deficiency Anemia of Pregnancy; Iron Metabolism Disorders; Glucose Intolerance; Gestational Diabetes.

• week of pregnancy 24-28
• pre-pregnancy BMI <27.5kg/m2
• singleton pregnancy
• Hb > 8.0 g/dl

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

100mg iron fumarate; Burgerstein Schwangerschaft & Stillzeit

Registered summary

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented. The full summary is on the listing.

Where, as registered

No US site; Switzerland (1).

Who the trial lists, as registered

Lists people 18 to 99; healthy volunteers accepted. Conditions: Healthy Volunteers; Rectal Cancer Patients.

• Willing and able to give written informed consent for participation in the trial.
• Healthy male participant, or female participant of non-childbearing potential aged 18 to 50 years, inclusive.
• Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at the time of the screening visit.
• Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Iron oxide nanoparticles; Rectal Magnetomotoric ultrasound (MMUS); Iron oxide nanoparticles; Iron oxide nanoparticles; Iron oxide nanoparticles

Registered summary

Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. If new imaging techniques for clinical staging of early rectal cancer are developed an opportunity for increased treatment by local excision and decreased unnecessary radical surgery would be possible. The full summary is on the listing.

Where, as registered

No US site; Sweden (1).

Who the trial lists, as registered

Lists female participants 18 and older; healthy volunteers accepted. Conditions: Iron Deficiency Anemia Treatment; Iron Deficiency; Iron Deficiency (Without Anemia).

• Undergoing natural perimenopause
• English-speaking
• In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition

The exclusion criteria are on the listing.

What it tests, as registered

FeoSol Original Iron Supplement Tablets; 21st Century Gelatin Capsules

Registered summary

The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: * What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? * How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? The investigators will compare the effect of iron supplements to a placebo… The full summary is on the listing.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Gastric Adenocarcinoma.

• Age 18 or older
• Willing to provide informed consent
• Biopsy proven gastric cancer, undergoing curative-intent gastrectomy
• No distant metastases

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Gastrectomy; Indocyanine Green; Iron Conjugated Polymers in Saline Suspension

Registered summary

This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.

Where, as registered

1 US site in 1 state.

Who the trial lists, as registered

Lists female participants 18 and older. Conditions: Anemia; Iron Deficiency Anaemia in Childbirth; Pregnancy.

• Pregnancy

The exclusion criteria are on the listing.

What it tests, as registered

Iron

Registered summary

During pregnancy, iron deficiency is the most common cause of anemia. Anemia is very common during pregnancy and after childbirth. Around half of pregnant women develop anemia, and after delivery, up to 85% of women may be affected. This study looks at whether iron given through a vein (intravenous iron) can improve blood levels and how women feel and function in everyday life before and after giving birth.

Where, as registered

No US site; Germany (2).

Who the trial lists, as registered

Lists female participants 18 to 45; healthy volunteers accepted. Conditions: Anemia of Pregnancy; Iron Deficiency Anemia.

• Pregnant females; gestational age from 14 to 16 weeks Age 18-45 years
• Low-risk pregnancy is defined as a pregnancy in which there is no high risk of problems or unfavorable outcomes, and the expectant mother and fetus are typically healthy
• Non-anemic women at the time of recruitment (hemoglobin level not less than 10.5. Hemoglobin measured within 2 or 3 weeks of recruitment
• Singleton pregnancy

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

30 mg liposomal iron, capsules

Registered summary

Protocol Summary: Liposomal Iron Supplementation in Non-anemic Pregnant Females This observational study aims to evaluate the efficacy and safety of daily liposomal iron supplementation (30 mg) in non-anemic pregnant women during their second trimester of pregnancy. The study will focus on pregnant females aged 18-45 years with low-risk, singleton pregnancies who are non-anemic (hemoglobin ≥10.5) at 14-16 weeks gestation. The full summary is on the listing.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists female participants 18 and older; healthy volunteers accepted. Conditions: Maternal Anemia; Micronutrient Deficiency; Pregnancy Outcomes; Maternal Nutrition.

• Pregnant women aged 18 years or older
• Gestational age ≤20 weeks at enrollment
• Singleton pregnancy
• Hemoglobin concentration ≥10 g/dL at baseline

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Multiple Micronutrient Supplementation (MMS); Iron-Folic Acid (IFA)

Registered summary

This study aims to compare the effectiveness of Multiple Micronutrient Supplementation (MMS), Iron-Folic Acid (IFA) supplementation, and combined MMS+IFA supplementation among pregnant women. Maternal anemia and micronutrient deficiencies are common during pregnancy and can adversely affect both maternal and neonatal health outcomes. A total of 402 pregnant women with gestational age of 20 weeks or less will be randomly assigned to receive MMS, IFA, or combined MMS+IFA supplementation. Participants will be followed throughout pregnancy until delivery. The full summary is on the listing.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 6 months to 6 months. Conditions: Iron Deficiencies.

• Subject's caregiver is willing and able to give informed consent
• Male or Female, 6 months (+/- 2 weeks) of age
• Mother at least ≥15 years of age
• Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) >61 μmol/mol heme)

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Iron syrup; Multivitamin syrup; R21-Matrix/M Vaccine (malaria vaccine); Measles-Rubella vaccine

Registered summary

Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination. In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 18 to 75. Conditions: Gastric Cancer (GC); Iron Deficiency Anemia (IDA); Post-Operative Anemia; Radical Gastrectomy.

• Age 18 to 75 years, sex male or female, and body weight ≥ 50 kg.
• Histopathologically confirmed gastric cancer (TNM stage I-III according to the AJCC 8th edition) and have undergone curative (R0) resection.
• Postoperative anemia defined as a hemoglobin (Hb) level < 100 g/L within 24 hours after surgery (i.e., on postoperative day 1), meeting the diagnostic criteria for postoperative anemia in gastric cancer patients.
• Evidence of iron deficiency, as indicated by:

9 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Ferric Carboxymaltose (FCM); Iron Sucrose.

Registered summary

This is a multicenter, open-label, randomized controlled trial. A total of 160 patients with iron-deficiency anemia after radical gastrectomy for gastric cancer will be enrolled and randomly assigned in a 1:1 ratio. Subjects in the experimental group will receive a single-dose intravenous ferric carboxymaltose on postoperative day 1, while the control group will receive multiple intravenous infusions of iron sucrose to achieve an identical total iron dose. All participants will follow standardized postoperative nutritional support and transfusion criteria. The full summary is on the listing.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 18 months to 18. Conditions: Celiac Disease in Children; Iron Deficiency.

• Children aged 18 months to 18 years
• Newly diagnosed with celiac disease (based on ESPGHAN guidelines)
• Ferritin levels below 15 ng/dL
• Normal hemoglobin, MCV, and MCH levels for age and sex

The exclusion criteria are on the listing.

What it tests, as registered

Iron (III) Hydroxide Polymaltose (50 mg/5 mL); Gluten-free diet

Registered summary

This study aims to understand how to best manage iron deficiency in children newly diagnosed with celiac disease. Many children with celiac disease have low iron levels, even if they do not have anemia. While some doctors recommend iron supplements, others believe that simply following a gluten-free diet may be enough to restore iron levels naturally. The full summary is on the listing.

Where, as registered

No US site; Israel (5).

Who the trial lists, as registered

Lists people 18 to 70. Conditions: Anemia, Iron Deficiency.

• Adult patients (≥18 years) scheduled for elective open heart surgery (CABG), with a minimum preoperative waiting period of 8-12 weeks and presenting with preoperative hemoglobin levels of 10-11 g/dL in females and 11-12 g/dL in males, were…
• Moderate to good LV (EF 40 and above)

The exclusion criteria are on the listing.

What it tests, as registered

Immune Modulating Formula, Whey Protein, Multivitamins and Iron Supplements

Registered summary

1. To test the effect and feasibility of culturally relevant SNP program in Anaemic patients scheduled for elective open-heart surgery versus those getting usual preoperative care in a public sector hospital. 2. To evaluate the incidence of transfusion during intra-operative and postoperative periods among cardiac patients undergoing elective open-heart surgery who receive iron correction therapy as part of the Solo Nutrition Prehabilitation (SNP) program

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Iron-deficiency; Colorectal Cancer.

• Planned for curative intended elective colon or rectum cancer surgery
• UICC stage I-III (at diagnosis)
• Hemoglobin > 7.0 mmol/L
• Serum ferritin <101 microgram/L or transferrin saturation <21%

The exclusion criteria are on the listing.

What it tests, as registered

Iron(III)isomaltoside; Placebo

Registered summary

This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. The full summary is on the listing.

Where, as registered

No US site; Denmark (3).

Who the trial lists, as registered

Lists female participants 18 and older; healthy volunteers accepted. Conditions: Pregnancy Related.

• Attending first ANC visit at the study clinic
• Pregnant women ≤ 15 weeks of gestation
• Aged ≥ 18 years
• Intending to stay in the study area for the duration of study

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Iron Folic Acid Tablets with 60 mg of iron; Multiple Micronutrient Supplements with 60 mg of elemental iron

Registered summary

This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Where, as registered

No sites listed yet.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Renal Anemia; Peritoneal Dialysis (PD).

• Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg
• Hemoglobin(Hb）≤110 g/L at screening phase
• Serum ferritin(SF）≤200 μg/L or transferrin saturation(TSAT）≤20% at screening phase
• No oral or intravenous iron use within 4 weeks prior to screening.

3 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Iron isomaltoside; Ferrous succinate

Registered summary

This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets. The main questions to answer are: * Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia. The full summary is on the listing.

Where, as registered

No sites listed yet.