Non-Alcoholic Fatty Liver DiseasePhase 1NCT05897606
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD
A Phase 1 study testing Multiviamins and minerals in people with Non-Alcoholic Fatty Liver Disease, run by Sulaimani Polytechnic University at 1 site in Iraq.
Trial summary
The study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD Read more about this study
- Who is it for?
- Ages 22 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Multiviamins and minerals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2023to 3 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with NAFLD diagnosed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Multiviamins and minerals, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiviamins and mineralsCombination product
The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
PlaceboCombination product
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Multiviamins and minerals |
| Placebo | Placebo comparator | the control group took a placebo prepared with the same shape and size of supplements. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Feb 2023
- Primary completion2 May 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group received multivitamin and minerral
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sulaimani Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hawal Lateef Fateh, Sulaimani Polytechnic University
- Investigators
- HAWAL F Lateef, Msc, Principal investigator, Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897606
- Sponsor's protocol ID
- KTC1211
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With Non-alcoholic Fatty Disease (NAFLD); RCR
- ClinicalTrials.gov ID
- NCT05897606
- Acronym / sponsor ID
- KTC1211
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Sulaimani Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group received multivitamin and minerral
| Arm | Type | Receives |
|---|---|---|
| effect multivitamin and minerals on NAFLD for 12 weeks | Experimental | Combination Product: Multiviamins and mineralsThe intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks. |
| Placebo | Placebo comparator | Combination Product: Placebothe control group took a placebo prepared with the same shape and size of supplements. |
Who may qualify
- Ages
- 22 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants with NAFLD diagnosed
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiviamins and mineralsThe intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks. | Combination product | effect multivitamin and minerals on NAFLD for 12 weeks |
| PlaceboPlacebo | Combination product | Placebo |
Primary outcome
Multivitamin and minerals supplementation has role in reduce liver enzymes
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAWAL F Lateef, Msc principal investigator
Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multiviamins and minerals in people with Non-Alcoholic Fatty Liver Disease, run by Sulaimani Polytechnic University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivitamin and minerals supplementation has role in reduce liver enzymes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.