Cardiovascular DiseasesNCT03442283
Meta-analysis of Randomized Controlled Trials on Vitamins and Mineral Supplementation for CVD Prevention and Treatment
An observational study of Cardiovascular Diseases, run by University of Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Vitamin mineral supplementation
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults free of serious chronic disease infections.
Who may be able to join
- English studies
- Supplements taken orally for at least 6 months
Who cannot join
- 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)
About this study
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
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.
Read the 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).
- Conditions
- Cardiovascular Diseases
- Being tested
- Vitamin mineral supplementation
- Keywords
- Supplements, Cardiovascular Diseases, All-cause mortality, Meta-Analysis
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin mineral supplementationDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Not described Receives: Dietary Supplement: Vitamin mineral supplementation | |
| No Supplementation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease (CVD)
Measured: 1 year
Coronary heart disease (CHD)
Measured: 1 year
Myocardial infarction (MI)
Measured: 1 year
Stroke
Measured: 1 year
CVD mortality
Measured: 1 year
CHD mortality
Measured: 1 year
MI mortality
Measured: 1 year
stroke mortality
Measured: 1 year
All-cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startJul 2016
- Primary completionApr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442283
- Sponsor's protocol ID
- META SUPPLEMENTS 001
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03442283
- Acronym / sponsor ID
- META SUPPLEMENTS 001
- Conditions
- Cardiovascular Diseases
- Keywords
- Supplements, Cardiovascular Diseases, All-cause mortality, Meta-Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 22 Feb 2018 (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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplementation | – | Dietary Supplement: Vitamin mineral supplementation |
| No Supplementation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults free of serious chronic disease infections.
Key inclusion criteria (2 listed)
- English studies
- Supplements taken orally for at least 6 months
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Vitamin mineral supplementationsupplementation 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. | Dietary supplement | Supplementation |
Primary outcome
Cardiovascular disease (CVD)
Time frame: 1 year
Coronary heart disease (CHD)
Time frame: 1 year
Myocardial infarction (MI)
Time frame: 1 year
Stroke
Time frame: 1 year
CVD mortality
Time frame: 1 year
CHD mortality
Time frame: 1 year
MI mortality
Time frame: 1 year
stroke mortality
Time frame: 1 year
All-cause mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Toronto.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Cardiovascular disease (CVD) (time frame: 1 year). The study lists 9 primary outcomes in all. 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 26 Feb 2018.