[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649789":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":58,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":89,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Tabriz University of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL",null,[13],"Dietary Supplement: 5-methyltetrahydrofolate (5-MTHF)",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Dietary Supplement: placebo group",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"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).",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"placebo group","Patients in this group will receive placebo for 90 days. The placebo is corn starch\u002F cellulose and will be consumed once a day. Placebo tablets will be manufactured by Ashbal Chemi Co. (Tehran, Iran).",[15],[30],{"name":31,"affiliation":5,"role":32},"Bahram Pourghassem Gargari","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Fatemeh Tamjid, MSc, PhD student","CONTACT","+989144755462","tamjid.f@tbzmed.ac.ir",{"name":40,"role":36,"phone":41,"phoneExt":11,"email":42},"Bahram Pourghassem Gargari, PhD. Professor at TUMS","+989143165247","pourghassemb@tbzmed.ac.ir, bahrampg@yahoo.com",[44],{"facility":45,"status":11,"city":46,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Liver Clinic of Valiasr Hospital (Tabriz, Iran)","Tabriz","Iran","IR",{"type":50,"coordinates":51},"Point",[52,53],46.2919,38.08,{"lat":53,"lon":52},[56,57],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":11,"email":42},{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Fatemeh Tamjid","Principal Investigator","100649789","the-effects-of-5-methyltetrahydrofolate-supplementation-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-100649789",false,"NCT07740109","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","MASLD","Inclusion Criteria:\n\n* Adult men or women (18-50 years)\n* Diagnosis of MASLD (grade 1 or 2 of steatosis confirmed by ultrasound)\n* Body mass index (BMI) = 25-34.9 kg\u002Fm²\n* Providing written informed consent\n\nExclusion Criteria:\n\n* Pregnancy, lactation, or plans to get pregnant during the next three months.\n* 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\n* Taking drugs affecting glucose or lipid metabolism, folate supplements, anti-obesity medications, weight-loss diets, or dietary supplements\n* Lifestyle factors known to impact folate status (current smoking, alcohol intake, recreational drug use)\n* 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\u002Fanemia)\n* Medications that interfere with B-vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, phenytoin, primidone, triamterene, barbiturates)","ALL","18 Years","50 Years",{"count":73,"type":74},44,"ESTIMATED","INTERVENTIONAL",[77],"NA","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",[80,81,82,67,83,84,85,86,87,88],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease (NAFLD)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","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",[90,91,67,83,80,84],"5-methyltetrahydrofolate","homocysteine","NOT_YET_RECRUITING","2026-07-30",{"date":95,"type":96},"2026-07-31","ACTUAL",{"date":98,"type":74},"2026-09-30",{"date":100,"type":74},"2027-08-30",{"name":5,"class":6},1]