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Omega-3 Fatty Acid

Vitamin D + Omega-3 for Preventing Major Diseases

N/A
Waitlist Available
Led By Meryl S LeBoff, M.D.
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
All participants from the VITAL parent study (NCT01169259) were enrolled in this ancillary study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years

Summary

This trial is investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

Who is the study for?
This trial is for U.S. men and women who were part of the VITAL parent study, looking at whether daily supplements of vitamin D3 or omega-3 fatty acids can prevent cancer, heart disease, and stroke in those without a history of these conditions.
What is being tested?
The study tests if taking vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) daily reduces the risk of broken bones. It also explores if vitamin D's effect on bone fractures is influenced by genetic factors related to vitamin D levels.
What are the potential side effects?
Potential side effects from Vitamin D3 may include high calcium levels, kidney stones, or digestive issues. Omega-3s might cause fishy burps, bleeding risks, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Fracture

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D + fish oil placeboActive Control2 Interventions
Group II: Vitamin D placebo + fish oilActive Control2 Interventions
Group III: Vitamin D + fish oilActive Control2 Interventions
Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,851,945 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,064,147 Total Patients Enrolled
Meryl S LeBoff, M.D.Principal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
26,642 Total Patients Enrolled

Media Library

Fish Oil (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01704859 — N/A
Broken Bones Research Study Groups: Vitamin D placebo + fish oil placebo, Vitamin D + fish oil placebo, Vitamin D placebo + fish oil, Vitamin D + fish oil
Broken Bones Clinical Trial 2023: Fish Oil Highlights & Side Effects. Trial Name: NCT01704859 — N/A
Fish Oil (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01704859 — N/A
~0 spots leftby Dec 2024
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