Status:
ACTIVE_NOT_RECRUITING
Vitamin D and Omega-3 Trial (VITAL)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cancer
Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The VITamin D and OmegA-3 TriaL (VITAL) 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 acid...
Detailed Description
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial of vitamin D (in the form of vitamin D3 \[cholecalciferol\]) and marine omega-3 fatty acid (eicosapentaenoic acid \[EPA\] + docos...
Eligibility Criteria
Inclusion
- To be eligible for the study, respondents had to, at study entry,:
- be men aged 50 or older or women aged 55 or older;
- have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention;
- have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's);
- have no allergy to fish or soy;
- have no other serious illness that would preclude participation;
- be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
- be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
- not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
25871 Patients enrolled
Trial Details
Trial ID
NCT01169259
Start Date
July 1 2010
End Date
May 1 2026
Last Update
November 6 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215