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

NCT07740109 | Not Yet Recruiting DMC

• 1 other identifier: IRCT20100123003140N26
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Fatty Liver Disease (NAFLD); MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease; MASLD; NAFLD; Metabolic Dysfunction-Associated Steatotic Liver Disease; NAFLD - Nonalcoholic Fatty Liver Disease

Keywords

5-methyltetrahydrofolate; homocysteine; MASLD; NAFLD; Nonalcoholic Fatty Liver Disease; Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

Primary Outcomes (3)

• Serum folate level

  Changes in serum folate level pre and post the 3-month intervention period.

  3 months

• Serum homocysteine level

  Changes in serum homocysteine level pre and post the 3-month intervention period.

  3 months

• Expression of PPARα and TNFα genes

  Changes in expression of PPARα and TNFα genes pre and post the 3-month intervention period.

  3 months

Secondary Outcomes (14)

• Liver biochemical parameters (ALT (alanine aminotransferase), AST (aspartate aminotransferase), and GGT (gamma-glutamyl transferase)

  3 months

• The fibrosis-4 (FIB-4) index

  3 months

• Quality of life using SF-36 (36-Item Short Form Health Survey) questionnaires

  3 months

• Lipid profile (triglycerides, total cholesterol, LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol))

  3 monhs

• Fasting blood glucose

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Dietary Supplement: 5-methyltetrahydrofolate (5-MTHF)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo group

Interventions

5-methyltetrahydrofolate (5-MTHF) DIETARY_SUPPLEMENT

Patients in this group will receive 5-methyltetrahydrofolate tablets (800 mcg) once a day for 90 days. Tablets will be manufactured by Ashbal Chemi pharmaceutical company (Qfol, Ashbal Chemi Co., Tehran, Iran).

Intervention

placebo group DIETARY_SUPPLEMENT

Patients in this group will receive placebo for 90 days. The placebo is corn starch/ cellulose and will be consumed once a day. Placebo tablets will be manufactured by Ashbal Chemi Co. (Tehran, Iran).

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead

Study Sites (1)

Liver Clinic of Valiasr Hospital (Tabriz, Iran)

Tabriz, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

5-methyltetrahydrofolate

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Bahram Pourghassem Gargari

  Tabriz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatemeh Tamjid, MSc, PhD student

CONTACT

+989144755462; tamjid.f@tbzmed.ac.ir

Bahram Pourghassem Gargari, PhD. Professor at TUMS

CONTACT

+989143165247; pourghassemb@tbzmed.ac.ir, bahrampg@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)