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

Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With Non-alcoholic Fatty Disease (NAFLD); RCR

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

Study Overview

• Status: Completed
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Combination product: Placebo; Combination product: Multiviamins and minerals

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Kalar
    • Kurdistan, Kalar, Iraq, 46021
      • Hawal Fateh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: effect multivitamin and minerals on NAFLD for 12 weeks; The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.	Combination product: Multiviamins and minerals; The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
Placebo Comparator: Placebo; the control group took a placebo prepared with the same shape and size of supplements.	Combination product: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multivitamin and minerals supplementation has role in reduce liver enzymes	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.	12 weeks

Collaborators and Investigators

• Sponsor: Sulaimany Polytechnic university
• Investigators: Principal Investigator: HAWAL F Lateef, Msc, Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: KTC1211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes