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5-methyltetrahydrofolate supplement for people with fatty liver disease linked to metabolic problems

Tests 5-methyltetrahydrofolate against placebo in adults with metabolic dysfunction-associated steatotic liver disease.

Plain-language title generated from the registry record
Registry title: The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Key facts

Where
Tabriz, IranSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 50 with fatty liver disease (MASLD) and a body mass index of 25 to 34.9. It tests a folate supplement (5-MTHF) against a placebo.

Age
18 to 50 years
Sex
Men and women
Disease stage
MASLD with grade 1 or 2 fatty liver, confirmed by ultrasound. Body mass index (BMI) 25 to 34.9 kg/m².
Earlier treatment
People cannot join if they take drugs that affect sugar or fat metabolism, folate supplements, weight-loss drugs, other dietary supplements, or follow a weight-loss diet.

Main reasons for not taking part

  • Pregnancy, breastfeeding, or plans to get pregnant in the next three months
  • Other liver disease, heart or kidney failure, cancer, or high blood pressure
  • Type 1 or type 2 diabetes
  • Current smoking, alcohol use, or recreational drug use
  • Conditions or medicines that affect folate or B-vitamin levels

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Source: NCT07740109, who can take part

Where in Iran

  • Liver Clinic of Valiasr Hospital (Tabriz, Iran)Tabriz, IranContact: Fatemeh Tamjid, MSc, PhD studentNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Tabriz University of Medical Sciences
Trial code
NCT07740109
Record updated
31 July 2026
Original description
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 MASLDRead full original descriptionShow less

The Effect of 5-methyltetrahydrofolate Supplementation on Serum Folate and Homocysteine Level and PPARα and TNFα Gene Expression in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: a Double-blind, Parallel Randomized Controlled Trial Study

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

Inclusion: 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: Lifestyle factors known to impact folate status (current smoking, alcohol intake, recreational drug use); Medications that interfere with B-vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, phenytoin, primidone, triamterene, barbiturates); 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; 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); Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements; Pregnancy, lactation, or plans to get pregnant during the next three months.

ClinicalTrials.gov NCT07740109