Folate (methylfolate vs folic acid) trials recruiting now
16 registrations that name folate as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 16 registrations
Status
Phase
All 16 registrations
RecruitingNCT05708183
Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia
Observational
London School of Hygiene and Tropical Medicine
About 25,620 people
Started Jan 1, 2023
In plain words An observational study of folate in female participants 15 to 49, run by London School of Hygiene and Tropical Medicine. It plans to enroll about 25,620 people at 6 sites, none in the US.
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).
RecruitingNCT07695883
Micronutrient Enhancement for Development and Health in Adolescents - The MEDHA Study
Phase 3
Johns Hopkins Bloomberg School of Public Health
About 3,000 people
Started Sep 27, 2026
In plain words A Phase 3 study of folate in female participants 10 to 18, run by Johns Hopkins Bloomberg School of Public Health. It plans to enroll about 3,000 people at 1 site, none in the US.
Who it lists and where
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).
RecruitingNCT06285357
The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.
No phase
Lo.Li.Pharma s.r.l
About 100 people
Started Feb 19, 2024
In plain words A study of folate in female participants 25 to 65, run by Lo.Li.Pharma s.r.l. It plans to enroll about 100 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 25 to 65. Conditions: HPV Infection.
HR-HPV DNA test positivity
The exclusion criteria are on the listing.
What it tests, as registered
EGCG + folic acid + B12
Registered summary
The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix.
Where, as registered
No US site; Italy (1).
RecruitingNCT07770711
Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS
No phase
Dicle University
About 90 people
Started Aug 13, 2026
In plain words A study of folate in female participants 20 to 40, run by Dicle University. It plans to enroll about 90 people at 1 site, none in the US.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. The full summary is on the listing.
Where, as registered
No US site; Turkey (Türkiye) (1).
RecruitingNCT07685015
The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus
No phase
Medical University of Vienna
About 40 people
Started Mar 23, 2026
In plain words A study of folate in female participants 18 to 45, run by Medical University of Vienna. It plans to enroll about 40 people at 2 sites, none in the US.
The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. The full summary is on the listing.
Where, as registered
No US site; Austria (2).
Not yet recruitingNCT07377071
Folate Treatment to Reduce Death Risk in the Year After Infection-Related Acute Kidney Injury
Early phase 1
The University of Hong Kong
About 382 people
Starts Apr 1, 2026 (estimated)
In plain words An early phase 1 study of folate in people 18 and older, run by The University of Hong Kong. It plans to enroll about 382 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Infection-Associated Acute Kidney Injury.
Adults ≥18 years of age
Presence of an infection (defined by clinical signs/symptoms such as fever, chills, or laboratory evidence; or presumed infection indicated by blood culture obtained and at least 4 Qualifying Antimicrobial Days starting within 2 calendar…
Diagnosed with AKI based on KDIGO criteria: increase in serum creatinine by ≥0.3 mg/dL (26.5 µmol/L) within 48 hours, OR increase to ≥1.5 times baseline, OR urine output <0.5 mL/kg/h for ≥6 hours (baseline creatinine is the median from…
Ability to provide informed consent or having a legally authorized representative to provide consent
The exclusion criteria are on the listing.
What it tests, as registered
Folic Acid 5 MG
Registered summary
The goal of this clinical trial is to evaluate if taking folic acid (a form of vitamin B9) can help reduce the risk of death and improve kidney recovery in adults with acute kidney injury (AKI) caused by infections or sepsis. The main question it aims to answer is: Does taking folic acid lower the chance of dying within one year for these patients? This study will also look at other important questions, such as whether folic acid helps kidneys recover faster (within 7 days), prevents long-term kidney problems (progression to chronic kidney disease at 3 months), reduces heart-related events,… The full summary is on the listing.
Where, as registered
No US site; Hong Kong (1).
Not yet recruitingNCT06069856
Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial
Phase 3
George Washington University
About 130 people
Starts Jun 1, 2027 (estimated)
In plain words A Phase 3 study of folate in female participants 18 and older, run by George Washington University. It plans to enroll about 130 people and lists no sites yet.
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.
Not yet recruitingNCT05861648
Folic Acid Supplementation in Calcific Aortic Valve Disease
Phase 2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
About 100 people
Starts Jul 1, 2023 (estimated)
In plain words A Phase 2 study of folate in people 35 and older, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. It plans to enroll about 100 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 35 and older. Conditions: Calcification of Aortic Valve; Aortic Valve Stenosis.
Male or female adult ≥ 35 years of age at the time of recruiting.
Subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on…
Subject provides written informed consent prior to initiation of any study procedures.
Subject understands and agrees to comply with planned study procedures.
The exclusion criteria are on the listing.
What it tests, as registered
Folic Acid Oral Tablet; Placebo
Registered summary
This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07013136
Feasibility Test of Folic Acid on Acute Kidney Injury
Early phase 1
The University of Hong Kong
About 90 people
Starts Oct 1, 2025 (estimated)
In plain words An early phase 1 study of folate in people 18 and older, run by The University of Hong Kong. It plans to enroll about 90 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 and older. Conditions: Acute Kidney Injury.
Adults ≥18 years of age;
AKI;
Intended or existing hospitalisation;
No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the study;
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Folic Acid 5 MG
Registered summary
The goal of this clinical trial is to evaluate the feasibility of folic acid supplementation as a treatment for adult patients with acute kidney injury (AKI) receiving hospital care. The main question it aims to answer is: Is it feasible to conduct a fully-powered randomized controlled trial (RCT) to assess the efficacy and safety of folic acid supplementation in AKI management? Researchers will compare two groups (usual care vs. usual care + 5 mg folic acid) to determine the feasibility of folic acid supplementation and estimate the sample size required for a fully powered RCT. The full summary is on the listing.
Where, as registered
No US site; Hong Kong (1).
Not yet recruitingNCT03585738
Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women
No phase
Università degli Studi dell'Insubria
About 80 people
Starts Jan 1, 2022 (estimated)
In plain words A study of folate in female participants 18 to 40, run by Università degli Studi dell'Insubria. It plans to enroll about 80 people and lists no sites yet.
Pregnancy spontaneously conceived in women with PCOS diagnosed by Rotterdam criteria that starts oral supplementation before conception.
The exclusion criteria are on the listing.
What it tests, as registered
Inositol + Folic acid; Folic acid
Registered summary
Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. The full summary is on the listing.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07835737
Safety and Efficacy of Folic Acid Combined With Atezolizumab and Bevacizumab as First-Line Therapy for Unresectable Hepatocellular Carcinoma
Phase 1 and 2
West China Hospital
About 78 people
Starts Oct 1, 2026 (estimated)
In plain words A Phase 1 and 2 study of folate in people 18 to 75, run by West China Hospital. It plans to enroll about 78 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 75. Conditions: Unresectable Hepatocellular Carcinoma.
Age 18 to 75 years, male or female, and willing to provide written informed consent.
Hepatocellular carcinoma (HCC) confirmed by histologic/cytologic examination or diagnosed according to accepted guideline-based clinical criteria.
Unresectable HCC as determined by multidisciplinary evaluation; BCLC stage B disease that is unsuitable for, declined, or has progressed after locoregional treatment, or BCLC stage C disease; candidate for first-line systemic therapy.
No prior systemic anticancer therapy for unresectable HCC. Prior locoregional treatment must have been completed at least 4 weeks before the first study treatment, with treatment-related toxicities recovered to Grade ≤1 or baseline.
10 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Folic Acid; Atezolizumab & Bevacizumab
Registered summary
This study is evaluating the safety and potential effectiveness of adding folic acid to atezolizumab plus bevacizumab as first-line treatment for adults with unresectable hepatocellular carcinoma (HCC). The main questions this study aims to answer are: Is daily folic acid safe and well tolerated when given together with atezolizumab and bevacizumab? What dose of folic acid should be recommended for further study? Does the combination show sufficient antitumor activity to support further clinical testing? This is an open-label, single-arm phase Ib/II study. The full summary is on the listing.
Where, as registered
No sites listed yet.
Not yet recruitingNCT07697196
Effect of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on HPV DNA Integration
No phase
IRCCS San Raffaele
About 42 people
Starts Jul 2026 (estimated)
In plain words A study of folate in female participants 25 and older, run by IRCCS San Raffaele. It plans to enroll about 42 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 25 and older. Conditions: HPV Infection; HPV Integration; HPV Disease; HPV Genital Infection; HPV Persistence; Low Grade Squamous Intraepithelial Lesions of the Cervix.
Age ≥ 25 years old
Positive HPV DNA test with genotyping 9-24 months prior to Day 0
Positive HPV DNA test with genotyping at Day 0
Presence of an HPV-related cervical lesion within 5-24 months prior to Day 0. This lesion will be defined alternatively as:
6 more inclusion criteria and the exclusion criteria are on the listing.
This interventional, single-center, open-label randomized clinical study evaluates the efficacy of an oral dietary supplement (Pervistop®) in women with persistent Human Papillomavirus (HPV) infection. The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7. The full summary is on the listing.
Where, as registered
No US site; Italy (1).
Not yet recruitingNCT06943482
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Phase 4
National University Hospital, Singapore
About 40 people
Starts Jul 1, 2025 (estimated)
In plain words A Phase 4 study of folate in female participants 21 to 60, run by National University Hospital, Singapore. It plans to enroll about 40 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 21 to 60. Conditions: Idiopathic Granulomatous Mastitis.
Women, aged between 21 and 60 years
Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results
This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.
Where, as registered
No US site; Singapore (1).
Not yet recruitingNCT07508917
Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
Phase 1 and 2
Fundació Sant Joan de Déu
About 36 people
Starts Apr 15, 2026 (estimated)
In plain words A Phase 1 and 2 study of folate in female participants 18 to 42, run by Fundació Sant Joan de Déu. It plans to enroll about 36 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 42. Conditions: Breastfeeding.
Maternal age between 18 and 42 years
Gestational age at birth ≥ 37 weeks.
Exclusive breastfeeding at enrollment.
Infant age 0-1 months
The exclusion criteria are on the listing.
What it tests, as registered
5-MTHF Supplementation; Placebo
Registered summary
This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored. Pre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. The full summary is on the listing.
Where, as registered
No US site; Spain (2).
Not yet recruitingNCT07461649
Pharmacokinetic Study of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) After Administration of CreNeuroS® CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting Conditions
No phase
Sichuan Credit Pharmaceutical Co., Ltd.
About 32 people
Starts Mar 15, 2026 (estimated)
In plain words A study of folate in people 18 to 45, run by Sichuan Credit Pharmaceutical Co., Ltd.. It plans to enroll about 32 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 18 to 45; healthy volunteers accepted. Conditions: Bioavailability and Pharmacokinetics.
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
Subjects whose screening laboratory values are within normal limits are considered by the physician or principal/clinical investigator to be of no clinical significance.
Healthy as documented by the medical history, physical examination and vital examinations.
Generally healthy, as documented by a 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments.
3 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
Registered summary
Demographic data, medical and medication history, physical examination, 12-lead ECG, haematology, biochemistry, serology, urine routine analysis, additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and a chest X-ray within 06 months prior to check-in. In study period, each group subjects will be housed in the clinical facility for at least -60.00 hours pre-dose to 72.00 hours post-dose.
Where, as registered
No US site; India (1).
Not yet recruitingNCT01687127
Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation
No phase
University of British Columbia
About 25 people
Starts Jan 1, 2024 (estimated)
In plain words A study of folate in female participants 20 to 35, run by University of British Columbia. It plans to enroll about 25 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 20 to 35; healthy volunteers accepted. Conditions: One-carbon Metabolism in Healthy Individuals.
Generally healthy
Body mass index of between 19-24 kg/m2
Normal folate, vitamin B12, and B6 status
The exclusion criteria are on the listing.
What it tests, as registered
Folic acid; 5-methyltetrahydrofolate, calcium salt
Registered summary
Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying biochemical mechanisms for how folic acid affects health outcomes however are unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as an adequate substitute to folic acid. This study aims to determine the effect of folic acid compared to 5-MTHF on cellular mechanisms. The full summary is on the listing.