Not Yet RecruitingNot Applicable

The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Iran44 participantsStarted 2026-09-30

Plain-language summary

To determine the effect of MTHF supplementation on serum folate and homocysteine level, metabolic, nutritional status, liver function, and PPARα and TNFα gene expression in patients with MASLD

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult men or women (18-50 years) * Diagnosis of MASLD (grade 1 or 2 of steatosis confirmed by ultrasound) * Body mass index (BMI) = 25-34.9 kg/m² * Providing written informed consent Exclusion Criteria: * Pregnancy, lactation, or plans to get pregnant during the next three months. * Liver disease (viral hepatitis, autoimmune liver disease, cirrhosis, drug-induced hepatotoxicity, or alcoholic fatty liver disease), heart or renal failure, kidney stones, any neoplasia, inflammatory disease, hypothyroidism, hypercortisolism, or hypertension * Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements * Lifestyle factors known to impact folate status (current smoking, alcohol intake, recreational drug use) * Pre-existing conditions affecting folate status (malabsorptive or inflammatory bowel diseases, active celiac disease, gastric bypass surgery, atrophic gastritis, epilepsy, advanced liver disease, kidney dialysis, type 1 or 2 diabetes mellitus, or sickle cell trait/anemia) * Medications that interfere with B-vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, phenytoin, primidone, triamterene, barbiturates)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing 5-methyltetrahydrofolate supplementation and measuring things like homocysteine and liver-related gene expression — can you explain what those markers tell us about my liver disease and whether changes in them are likely to translate into real benefits for me?
2Since this trial is listed as 'not yet recruiting,' do you know when it might open, and should I be pursuing other treatment options for my MASLD in the meantime rather than waiting for this study?
3This trial is listed as Phase NA, which suggests it may be an early or exploratory study — what does that mean for how much we'd know about the safety and effectiveness of this supplement before I'd be taking it as part of the study?
4The trial is looking at the expression of PPARα and TNFα genes — can you help me understand whether my specific stage or severity of MASLD would be relevant to what this study is trying to measure, and whether this kind of intervention might even apply to my situation?
5Are there already established treatments or lifestyle changes for MASLD that I should be trying first, and how would participating in a folate supplementation study fit alongside or potentially interfere with those options?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum folate level

Timeframe: 3 months

Serum homocysteine level

Timeframe: 3 months

Expression of PPARα and TNFα genes

Timeframe: 3 months

Trial details

NCT IDNCT07740109

SponsorTabriz University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-30

Contact for this trial

Fatemeh Tamjid, MSc, PhD student

+989144755462 tamjid.f@tbzmed.ac.ir

View on ClinicalTrials.gov More Nonalcoholic Fatty Liver Disease trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.