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

NCT ID: NCT05897606

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-05-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group received multivitamin and minerral
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Multiviamins and minerals

Intervention Type COMBINATION_PRODUCT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Placebo

Interventions

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Multiviamins and minerals

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

Intervention Type COMBINATION_PRODUCT

Placebo

Placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sulaimany Polytechnic university

OTHER

Sponsor Role lead

Responsible Party

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Hawal Lateef Fateh

Dr Hawal Lateef Fateh

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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HAWAL F Lateef, Msc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hawal Fateh

Kurdistan, Kalar, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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KTC1211

Identifier Type: -

Identifier Source: org_study_id

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