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

NCT07740109 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-07-31

No results posted yet for this study

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)
  • NAFLD (Non-alcoholic Fatty Liver Disease)
  • NAFLD - Non-Alcoholic Fatty Liver Disease
  • NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

DIETARY_SUPPLEMENT

5-methyltetrahydrofolate (5-MTHF)

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).

DIETARY_SUPPLEMENT

placebo group

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).

Sponsors & Collaborators

  • Tabriz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Bahram Pourghassem Gargari · Tabriz University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-08-30
Completion
2027-08-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07740109 on ClinicalTrials.gov