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临床试验/NCT03442283
NCT03442283Unknown不适用

Supplemental Vitamins and Minerals for CVD Prevention and Treatment: Systematic Review and Meta-analyses of the Data (Meta-analyses and RCTs) Published Since 2012

University of Toronto0 个研究点目标入组 1 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1
主要终点
CVD mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English studies
  • Supplements taken orally for at least 6 months

排除标准

  • 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)

结局指标

主要结局

CVD mortality

时间窗: 1 year

CHD mortality

时间窗: 1 year

MI mortality

时间窗: 1 year

stroke mortality

时间窗: 1 year

All-cause mortality

时间窗: 1 year

Cardiovascular disease (CVD)

时间窗: 1 year

Coronary heart disease (CHD)

时间窗: 1 year

Myocardial infarction (MI)

时间窗: 1 year

Stroke

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Jenkins

Professor

University of Toronto

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