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Meta-analysis of Randomized Controlled Trials on Vitamins and Mineral Supplementation for CVD Prevention and Treatment

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ClinicalTrials.gov Identifier: NCT03442283
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
David Jenkins, University of Toronto

Brief Summary:
The use of vitamin and mineral supplementation has historically been to treat and prevent micronutrient deficiencies. In recent years, however, and with their widespread use, the interest has shifted toward a possible role in the prevention and treatment of chronic diseases. The investigators will review and perform meta-analyses of vitamin and mineral supplementation trials in relation to cardiovascular disease. Publications from 2012, both before and including the US Preventive Service Task Force (USPSTF) 2014 review, will be included in the review.

Condition or disease Intervention/treatment
Cardiovascular Diseases Dietary Supplement: Vitamin mineral supplementation

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).


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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Supplemental Vitamins and Minerals for CVD Prevention and Treatment: Systematic Review and Meta-analyses of the Data (Meta-analyses and RCTs) Published Since 2012
Actual Study Start Date : July 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort Intervention/treatment
Supplementation Dietary Supplement: Vitamin mineral 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



Primary Outcome Measures :
  1. Cardiovascular disease (CVD) [ Time Frame: 1 year ]
  2. Coronary heart disease (CHD) [ Time Frame: 1 year ]
  3. Myocardial infarction (MI) [ Time Frame: 1 year ]
  4. Stroke [ Time Frame: 1 year ]
  5. CVD mortality [ Time Frame: 1 year ]
  6. CHD mortality [ Time Frame: 1 year ]
  7. MI mortality [ Time Frame: 1 year ]
  8. stroke mortality [ Time Frame: 1 year ]
  9. All-cause mortality [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults free of serious chronic disease infections.
Criteria

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)

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Responsible Party: David Jenkins, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03442283     History of Changes
Other Study ID Numbers: META SUPPLEMENTS 001
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Jenkins, University of Toronto:
Supplements, Cardiovascular Diseases, All-cause mortality, Meta-Analysis

Additional relevant MeSH terms:
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Cardiovascular Diseases
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs