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

NCT05897606 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: KTC1211
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

effect multivitamin and minerals on NAFLD for 12 weeks

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

the control group took a placebo prepared with the same shape and size of supplements.

Combination Product: Placebo

Interventions

Multiviamins and minerals COMBINATION_PRODUCT

The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.

effect multivitamin and minerals on NAFLD for 12 weeks

Placebo COMBINATION_PRODUCT

Placebo

Placebo

Eligibility Criteria

• Age: 22 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with NAFLD diagnosed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sulaimany Polytechnic university: lead

Study Sites (1)

Hawal Fateh

Kurdistan, Kalar, 46021, Iraq

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Minerals

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• HAWAL F Lateef, Msc

  Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: Dr Hawal Lateef Fateh

Model Details: Intervention group received multivitamin and minerral

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 9, 2023
• Study Start: February 1, 2023
• Primary Completion: May 2, 2023
• Study Completion: May 3, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)