Vitamin D + Fish Oil for Health Improvement

(VITAL Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Cancer, Heart disease, Stroke, others

Stay on Your Current Meds You can continue your current medications while participating

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

25871 Participants Needed

Trial Summary

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women 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. This ancillary study is being conducted among VITAL participants and will examine whether vitamin D or fish oil have effects upon A) autoimmune disease incidence, B) biomarkers of systemic inflammation, and C) chronic knee pain. Blood samples at baseline and in follow-up will be collected in a randomly selected subcohort of 1500 individuals and analyzed for changes in biomarkers of systemic inflammation: C-reactive protein, interleukin-6, and tumor necrosis factor-receptor 2. Approximately 1300 individuals with chronic, frequent knee pain will be followed with annual questionnaires to evaluate the effects of the supplements on chronic knee pain.

Research Team

Karen H Costenbader, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I frequently experience chronic knee pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dietary supplements of vitamin D3 or omega-3 fatty acids to assess effects on autoimmune disease, inflammation, and knee pain

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including annual questionnaires for knee pain and blood sample analysis for inflammation biomarkers

1 year

Extension

Observational follow-up for the development of new autoimmune diseases post trial closure

7 years

Treatment Details

Interventions

• Fish Oil
• Placebo Pill
• Vitamin D

Trial Overview 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.

Participant Groups

Group I: Vitamin D and Fish Oil Experimental Treatment 2 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 D Experimental Treatment 2 Interventions

Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Group III: Fish Oil Experimental Treatment 2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group IV: placebo Placebo Group 1 Intervention

Subjects will receive placebo pill.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in European Union as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in Canada as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+