Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD

Phase 1

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Combination Product: Multiviamins and minerals; Combination Product: Placebo

• Registration Number: NCT05897606
• Lead Sponsor: Sulaimany Polytechnic university

Brief Summary

The study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD

Detailed Description

This study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD.

Participants were randomly selected to participate in the study. Then divided into the groups (intervention and placebo). Intervention received supplementation for 12 weeks and placebo received same capsule was made for placebo groups.

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-03
• Study First Submitted: 2023-05-24
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Participants with NAFLD diagnosed

Exclusion Criteria

• subjects who in the last 6 months received vitamin or mineral supplementation, those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
effect multivitamin and minerals on NAFLD for 12 weeks	Multiviamins and minerals	The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
Placebo	Placebo	the control group took a placebo prepared with the same shape and size of supplements.

Primary Outcome Measures

Name	Time	Method
Multivitamin and minerals supplementation has role in reduce liver enzymes	12 weeks	Multivitamin and minerals supplement was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.

Trial Locations

Locations (1)

Hawal Fateh; 🇮🇶 Kurdistan, Kalar, Iraq