17 completed, 5 not yet recruiting, 3 recruiting, 2 withdrawn. 19 Not applicable, 4 Phase 3, 3 Phase 2, 3 Phase 4, 2 Phase 1.
Follow 5-methyltetrahydrofolate: new trials by email Literature Review of 5-methyltetrahydrofolate trials Research Report on 5-methyltetrahydrofolate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease 5-methyltetrahydrofolate (5-MTHF), placebo group - Nonalcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease (NAFLD) | Not applicable | Not yet recruiting | Tabriz University of Medical Sciences | 44 | 2026-09-30 | 2026-07-31 |
| 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 Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) - Bioavailability and Pharmacokinetics | Not applicable | Not yet recruiting | Sichuan Credit Pharmaceutical Co., Ltd. | 32 | 2026-03-15 | 2026-03-16 |
| 5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients active folate, Placebo - Type 1 Diabetes Mellitus | Not applicable | Not yet recruiting | Shanghai Changzheng Hospital | 34 | 2025-04-01 | 2025-04-16 |
| PREconception Folic Acid Clinical Efficacy (PREFACE) Trial Folic Acid, 5-MTHF (5-methyltetrahydrofolate) - Folate, Folate Bioavailability | Not applicable | Not yet recruiting | University of British Columbia | 272 | 2025-01-31 | 2024-10-21 |
| CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions CreNeuroS CNS Fish Oil Plus Softgel [380 mg of fish oil contains Eicosapentaenoic Acid (EPA) （as EE）342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals], Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules - Bioavailability | Not applicable | Enrolling by invitation | Sichuan Credit Pharmaceutical Co., Ltd. | 14 | 2025-01-03 | 2025-01-23 |
| Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women Folic Acid, 5-MTHF (5-methyltetrahydrofolate) - Pregnant Women | Not applicable | Completed | Dr. Soetomo General Hospital | 96 | 2025-01-01 | 2026-07-06 |
| Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study L-methylfolate - Generalized Anxiety Disorder | Phase 4 | Recruiting | Queen's University | 10 | 2024-10-22 | 2025-05-25 |
| China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype Amlodipine besylate, Amlodipine besylate And Folic Acid, 5-methyltetrahydrofolate (5-MTHF) - Hypertension, MTHFR 677 TT Genotype | Phase 4 | Recruiting | Shenzhen Ausa Pharmed Co.,Ltd | 24000 | 2024-08-22 | 2025-02-26 |
| Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation Folic acid, 5-methyltetrahydrofolate, calcium salt - One-carbon Metabolism in Healthy Individuals | Not applicable | Not yet recruiting | University of British Columbia | 25 | 2024-01-01 | 2023-08-15 |
| Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome Myo-Inositol + Levomefolic acid, Clomiphene Citrate, placebo - Polycystic Ovary Syndrome, Reproductive Medicine | Phase 3 | Recruiting | University Hospital, Lille | 276 | 2023-09-12 | 2026-04-22 |
| Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated With Elevated Serum Homocysteine in Hemodialysis Patients. L-Methyl Folate and methylcobalamine - End Stage Renal Disease, Hypertension, Renal | Phase 4 | Completed | Alexandria University | 51 | 2023-04-01 | 2025-01-13 |
| Combination Therapy of Different Antidepressants With Dietary Supplements L-methylfolate, Vitamin B12, magnesium - Depression | Not applicable | Completed | Riphah International University | 88 | 2022-10-05 | 2023-09-11 |
| Food and Alcohol Behavior Study: Meaningful Enhancement Methyl Folate, Placebo - Folate Deficiency | Not applicable | Unknown | Oklahoma State University Center for Health Sciences | 20 | 2019-08-14 | 2023-08-16 |
| Optimal Nutrition for Prevention of Hypertension in Pregnancy Riboflavin (5mg), 5-methyltetrahydrofolate (400µg), Placebo - Blood Pressure, Pregnancy | Not applicable | Active not recruiting | University of Ulster | 2250 | 2017-03-01 | 2025-10-07 |
| The Use Of L-Methylfolate As A Treatment For Depression L-methylfolate - Depression | Not applicable | Completed | University of Florida | 57 | 2016-02-01 | 2023-06-07 |
| Pilot Study: Combining Nutritional Supplements With Standard Antidepressant to Treat Depression. L-tyrosine, L-Tryptophan, deplin - Depression | Not applicable | Withdrawn | John D. Dingell VA Medical Center | 2015-11-01 | 2020-02-21 | |
| Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants infant formula containing folic acid, infant formula containing MTHF - Growth and Development | Not applicable | Completed | dsm-firmenich Switzerland AG | 360 | 2015-05-01 | 2018-08-10 |
| L-methylfolate Supplementation to OROS-Methylphenidate Pharmacotherapy in ADHD Adults L-methylfolate, OROS-Methylphenidate, Placebo - Attention Deficit Hyperactivity Disorder | Phase 2 / Phase 3 | Completed | Massachusetts General Hospital | 47 | 2014-05-01 | 2017-11-14 |
| Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America EE20/DRSP (BAY86-5300), EE20/DRSP/L-5-MTHF (BAY98-7071), EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660) - Contraception | Phase 3 | Withdrawn | Bayer | 2013-04-01 | 2014-07-15 | |
| Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate L-5-methyltetrahydrofolate (Metafolin ®), folic acid, Placebo - Vitamin B12 Deficiency | Not applicable | Completed | University of British Columbia | 150 | 2012-05-01 | 2012-08-10 |
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Depression (5) · Depressive Disorder, Major (2) · Abortion, Habitual (1) · Anxiety Disorders (1) · Attention Deficit Disorder with Hyperactivity (1) · Cystic Fibrosis (1) · Diabetes Mellitus, Type 1 (1) · Folic Acid Deficiency (1) · Generalized Anxiety Disorder (1) · Hyperhomocysteinemia (1) · Hypertension (1) · Hypertension, Renal (1) · Inflammation (1) · Ischemic Stroke (1) · Kidney Failure, Chronic (1)
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