NCT03442283

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

February 16, 2018

Last Update Submit

February 22, 2018

Conditions

Cardiovascular Diseases

Keywords

Supplements, Cardiovascular Diseases, All-cause mortality, Meta-Analysis

Outcome Measures

Primary Outcomes (9)

  • Cardiovascular disease (CVD)

    1 year

  • Coronary heart disease (CHD)

    1 year

  • Myocardial infarction (MI)

    1 year

  • Stroke

    1 year

  • CVD mortality

    1 year

  • CHD mortality

    1 year

  • MI mortality

    1 year

  • stroke mortality

    1 year

  • All-cause mortality

    1 year

Study Arms (2)

Supplementation

Dietary Supplement: Vitamin mineral supplementation

No Supplementation

Interventions

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.

Supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults free of serious chronic disease infections.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 22, 2018

Study Start

July 1, 2016

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share