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Omega-3 Fatty Acids

Vitamin D + Omega-3 for Osteoporosis

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
None of the following: allergy to soy or fish, hypercalcemia, renal failure or dialysis, severe liver disease, hypo- or hyperparathyroidism, sarcoidosis or other granulomatous diseases, or any other serious illnesses
No history of cardiovascular disease or cancer (excluding non-melanoma skin cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years

Summary

This trial found that vitamin K status was not associated with bone loss or fractures in postmenopausal women.

Who is the study for?
This trial is for men over 50 and women over 55 without cardiovascular disease or cancer, except non-melanoma skin cancer. Participants should not consume more than 1200 mg of calcium or take fish oil supplements during the trial. They must also avoid high doses of vitamin D (over 800 IU). People with severe liver disease, kidney failure, certain hormonal disorders, or other serious illnesses cannot join.
What is being tested?
The VITAL study examines how Vitamin D3 and Omega-3 fatty acids (fish oil) affect bone health in older adults. It's testing whether these supplements can help prevent osteoporosis and broken bones by improving calcium deposition in bones.
What are the potential side effects?
Potential side effects may include digestive discomfort from fish oil and too much calcium in the blood from Vitamin D3. However, specific side effects will depend on individual reactions to the supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have allergies to soy or fish, severe kidney, liver, or parathyroid issues, sarcoidosis, or other serious illnesses.
Select...
I have no history of heart disease or cancer, except for non-melanoma skin cancer.
Select...
I am a man over 50 or a woman over 55.

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
Number of Fractures
Secondary study objectives
Change in Areal Bone Density
Change in Bone Strength
Change in Cortical Thickness
+3 more

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
1,666 Previous Clinical Trials
11,814,364 Total Patients Enrolled
9 Trials studying Osteoporosis
64,665 Patients Enrolled for Osteoporosis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,063,641 Total Patients Enrolled
39 Trials studying Osteoporosis
41,241 Patients Enrolled for Osteoporosis
Meryl S LeBoff, M.D.Principal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
26,642 Total Patients Enrolled
1 Trials studying Osteoporosis
771 Patients Enrolled for Osteoporosis

Media Library

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT04573946 — N/A
Osteoporosis Research Study Groups: Vitamin D + fish oil placebo, Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo, Vitamin D + fish oil
Osteoporosis Clinical Trial 2023: Omega-3 fatty acids (fish oil) Highlights & Side Effects. Trial Name: NCT04573946 — N/A
Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04573946 — N/A
~4085 spots leftby Nov 2025
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