NCT07740109Not yet recruiting
The Effects of 5-methyltetrahydrofolate Supplementation in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Tabriz University of Medical Sciences
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07740109
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 30 Sept 2026 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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)
Lab values
- Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements
Other
- Pregnancy, lactation, or plans to get pregnant during the next three months.
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liver Clinic of Valiasr Hospital (Tabriz, Iran) Coordinator of this site? Confirm its status | Tabriz | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.