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Vitamin

Vitamin D + Fish Oil for Health Improvement (VITAL Trial)

N/A
Waitlist Available
Led By Karen H Costenbader, MD, MPH
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
As for the parent trial, VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259). Individuals with chronic, frequent knee pain at study baseline will be followed as a subcohort. Trial enrollment complete
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up extension of follow-up through 7 years post trial closure
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is studying whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids 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 without a history of cancer, heart disease, or stroke. It's focused on those with chronic knee pain due to conditions like rheumatoid arthritis and aims to see if vitamin D3 or fish oil supplements can help.
What is being tested?
The study tests whether daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of autoimmune diseases, lower inflammation markers, or alleviate chronic knee pain in participants.
What are the potential side effects?
Potential side effects from taking these supplements may include an upset stomach, fishy aftertaste from the fish oil, and possibly high calcium levels from too much vitamin D.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~extension of follow-up through 7 years post trial closure
This trial's timeline: 3 weeks for screening, Varies for treatment, and extension of follow-up through 7 years post trial closure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Autoimmune Diseases
Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)
Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)
+2 more
Secondary study objectives
Incident Autoimmune Disease
Other study objectives
Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With Vitamin D
Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110
12%
Back pain
7%
Arthralgia
3%
Fall
1%
Humerus fracture
1%
Hip fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D and Fish OilExperimental Treatment2 Interventions
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Group II: Vitamin DExperimental Treatment2 Interventions
Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
Group III: Fish OilExperimental Treatment2 Interventions
Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Group IV: placeboPlacebo Group1 Intervention
Subjects will receive placebo pill.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acids
FDA approved
Vitamin D
2013
Completed Phase 4
~3670

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
23 Trials studying Rheumatoid Arthritis
563,132 Patients Enrolled for Rheumatoid Arthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,063,641 Total Patients Enrolled
44 Trials studying Rheumatoid Arthritis
535,087 Patients Enrolled for Rheumatoid Arthritis
Karen H Costenbader, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Vitamin D (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT01351805 — N/A
Rheumatoid Arthritis Research Study Groups: placebo, Fish Oil, Vitamin D, Vitamin D and Fish Oil
Rheumatoid Arthritis Clinical Trial 2023: Vitamin D Highlights & Side Effects. Trial Name: NCT01351805 — N/A
Vitamin D (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01351805 — N/A
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT01351805 — N/A
~1687 spots leftby Nov 2025
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