- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03442283
Meta-analysis of Randomized Controlled Trials on Vitamins and Mineral Supplementation for CVD Prevention and Treatment
Supplemental Vitamins and Minerals for CVD Prevention and Treatment: Systematic Review and Meta-analyses of the Data (Meta-analyses and RCTs) Published Since 2012
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Search strategy:
A literature search of the Cochrane Library, Medline and PubMed will be conducted with the following search terms: "dietary supplements or supplement*" AND "cardiovascular disease or myocardial infarction or stroke or cardiovascular death or mortality or all-cause mortality or death." Specific searches will be conducted for individual supplements and included multivitamins, antioxidants, vitamin A, β-carotene, B1, B2, B3 (niacin), B6, B10 (folic acid), B-complex, C, D and E, calcium, iron, zinc, magnesium and selenium. The search will be limited to meta-analyses and RCTs.
Analysis:
Full article review and data extraction will be conducted by two independent investigators, with all disparities reconciled through consensus. The extracted data will include number of cases and total participants/population for the intervention and control group.
Data will be analyzed using Review Manager (RevMan) version 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) and publication bias will be conducted using STATA software, version 13.0 (College Station, TX, USA). Heterogeneity will be assessed using the Cochran Q statistic at p<0.1 and quantified by the I² statistic. Publication bias will be investigated by visual inspection of funnel plots and quantitative assessment using Begg's and Egger's tests where p<0.05 is considered evidence of small study effects. If <10 trials are available in a meta-analysis, publication bias analysis will not be assessed due to insufficient power.
Risk of bias The Cochrane risk of bias tool which is based on randomization, allocation concealment, blinding, completeness of follow-up and intention-to-treat will be used to assess eligible RCTs.
Grading of the evidence The quality and strength of the evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool. Using the GRADE tool, evidence will be graded as high, moderate, low, or very low quality evidence using the following criteria: study limitations (as assessed by the Cochrane Risk of Bias Tool), inconsistency (substantial) unexplained inter-study heterogeneity, I2>50% and p<0.1; indirectness (presence of factors that limit the generalizability of the results); imprecision (the 95% CI for effect estimates crosses a minimally important difference (MID) of 5% [RR 0.95-1.05]) from the line of unity; and publication bias (significant evidence of small-study effects).
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- English studies
- Supplements taken orally for at least 6 months
Exclusion Criteria:
- Studies in children
- Studies in women who are pregnant or breastfeeding
- Studies of adults who have serious chronic disease infections such as HIV
- Studies with combined interventions and no adequate control group (i.e. interventions other than the supplement must be provided to the control group as well)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Supplementation
|
supplementation with a vitamin or mineral: vitamin A, β-carotene, B1, B2, B3 (niacin), B6, B10 (folic acid), C, D and E, calcium, iron, zinc, magnesium and selenium.
Also, multivitamins, antioxidants, B-complex and the combination of calcium and vitamin D.
|
No Supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 1 year
|
1 year
|
Myocardial infarction (MI)
Time Frame: 1 year
|
1 year
|
Stroke
Time Frame: 1 year
|
1 year
|
Cardiovascular disease (CVD)
Time Frame: 1 year
|
1 year
|
Coronary heart disease (CHD)
Time Frame: 1 year
|
1 year
|
CVD mortality
Time Frame: 1 year
|
1 year
|
CHD mortality
Time Frame: 1 year
|
1 year
|
MI mortality
Time Frame: 1 year
|
1 year
|
stroke mortality
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- META SUPPLEMENTS 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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