Back to resultsEffect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Multiviamins and minerals
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
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.
Sites / Locations
- Hawal Fateh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
effect multivitamin and minerals on NAFLD for 12 weeks
Placebo
Arm Description
The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
the control group took a placebo prepared with the same shape and size of supplements.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05897606
First Posted
May 24, 2023
Last Updated
June 8, 2023
Sponsor
Sulaimany Polytechnic university
1. Study Identification
Unique Protocol Identification Number
NCT05897606
Brief Title
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD
Official Title
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With Non-alcoholic Fatty Disease (NAFLD); RCR
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 2, 2023 (Actual)
Study Completion Date
May 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sulaimany Polytechnic university
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Intervention group received multivitamin and minerral
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
effect multivitamin and minerals on NAFLD for 12 weeks
Arm Type
Experimental
Arm Description
The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
the control group took a placebo prepared with the same shape and size of supplements.
Intervention Type
Combination Product
Intervention Name(s)
Multiviamins and minerals
Intervention Description
The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Multivitamin and minerals supplementation has role in reduce liver enzymes
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAWAL F Lateef, Msc
Organizational Affiliation
Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawal Fateh
City
Kurdistan
State/Province
Kalar
ZIP/Postal Code
46021
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD
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