Active — Not RecruitingPhase 3

Vitamin D and Omega-3 Trial (VITAL)

United States25,871 participantsStarted 2010-07

Plain-language 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 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.

Who can participate

Age range50 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Number of Participants With Invasive Cancer of Any Type

Timeframe: 5 years

Number of Participants With a Major Cardiovascular Event

Timeframe: 5 years

Trial details

NCT IDNCT01169259

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-10

Results submitted2019-11-12

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