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Vitamin D + fish oil for Obesity (VITAL Trial)
N/A
Waitlist Available
Led By Jacqueline S. Danik, MD, DrPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants in VITAL (NCT 01169259) who are willing to participate in this ancillary study and undergo DXA evaluation (baseline and 2 years)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
VITAL Trial Summary
This trial is looking at whether taking daily supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke. This ancillary study is examining the effect of vitamin D or fish oil on changes in body composition and adiposity, and whether changes in cardiovascular risk factors are mediated by these parameters.
Eligible Conditions
- Obesity
VITAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVITAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Composition
Secondary outcome measures
Disulfiram
Adipokines
Anthropometric Measurements
+1 moreVITAL Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D placebo + fish oilActive Control1 Intervention
Vitamin D placebo and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Group II: Vitamin D + fish oilActive Control2 Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Group III: Vitamin D + fish oil placeboActive Control1 Intervention
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions
Vitamin D placebo and fish oil placebo
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Who is running the clinical trial?
American Heart AssociationOTHER
328 Previous Clinical Trials
4,933,233 Total Patients Enrolled
24 Trials studying Obesity
2,349 Patients Enrolled for Obesity
Brigham and Women's HospitalLead Sponsor
1,619 Previous Clinical Trials
11,471,081 Total Patients Enrolled
45 Trials studying Obesity
77,575 Patients Enrolled for Obesity
Jacqueline S. Danik, MD, DrPHPrincipal InvestigatorBrigham and Women's Hospital
Frequently Asked Questions
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