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Dietary Supplement

Vitamin D + Omega-3 for Osteoporosis and Body Composition (VITAL Trial)

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
* Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years

Summary

This trialis testing whether taking vitamin D and fish oil supplements prevents cancer, heart disease, and stroke in 25,871 U.S. men and women without prior illnesses. It also looks at the safety and efficacy of high-dose vitamin D on skeletal health and body composition.

Who is the study for?
The VITAL trial is for U.S. men and women who are part of the larger VITAL study, have no history of cancer, heart disease, or stroke, and aren't on bone-active medications currently or within the past year (or bisphosphonates within 2 years).
What is being tested?
This trial tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of serious diseases like cancer and heart disease in healthy individuals.
What are the potential side effects?
Potential side effects may include mild digestive discomfort from fish oil and possible high calcium levels or kidney stones from vitamin D3; however, these supplements are generally well-tolerated.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone Turnover Beta Crosslaps
Bone Turnover P1NP
Change in Bone Density
Secondary study objectives
Change in Bone Structure
Other study objectives
Body Composition

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D + fish oilActive Control2 Interventions
Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
Group II: Vitamin D placebo + fish oilActive Control2 Interventions
Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
Group III: Vitamin D + fish oil placeboActive Control2 Interventions
Daily vitamin D (2,000 IU/d) and daily fish oil placebo
Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions
Daily vitamin D placebo and daily fish oil placebo

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,247 Total Patients Enrolled
40 Trials studying Osteoporosis
66,382 Patients Enrolled for Osteoporosis
Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,877,495 Total Patients Enrolled
10 Trials studying Osteoporosis
91,318 Patients Enrolled for Osteoporosis
Meryl S LeBoff, M.D.Principal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
51,742 Total Patients Enrolled
1 Trials studying Osteoporosis
25,871 Patients Enrolled for Osteoporosis

Media Library

Vitamin D3 (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT01747447 — N/A
Osteoporosis Research Study Groups: Vitamin D + fish oil, Vitamin D placebo + fish oil, Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo
Osteoporosis Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT01747447 — N/A
Vitamin D3 (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01747447 — N/A
~58 spots leftby Dec 2025
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