Who is sponsoring NCT01632761?

NCT01632761 is sponsored by Brigham and Women's Hospital.

What drugs are being tested in NCT01632761?

Interventions: Vitamin D3 ., omega-3 fatty acids (fish oil), Vitamin D3 placebo, Fish oil placebo.

What is the status of NCT01632761?

NCT01632761 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-11-18 · How we verify

Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly

NCT01632761 NA ACTIVE_NOT_RECRUITING

The VITamin D and OmegaA-3 TriaL (VITAL; NCT01169259) is a randomized clinical trial in 20,000 U.S. men and women studying 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 study whether vitamin D or fish oil: (A) in the overall VITAL cohort, reduces the number of persons diagnosed with anemia and (B) in a subcohort of 900 participants seen in Boston, effects long-term changes of the proteins in blood in both anemic and non-anemic individuals who provide blood samples at the start of the study and again 2 years later.

Details

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	2000
Start date	2012-11
Completion	2025-12-28

Conditions

Anemia

Interventions

Vitamin D3 .
omega-3 fatty acids (fish oil)
Vitamin D3 placebo
Fish oil placebo

Primary outcomes

Incidence of Anemia — 2 years
We will compare the number of participants who took vitamin D supplements who developed anemia and the number of participants who did not take vitamin D who developed anemia to current rates of development of anemia in the U.S. We will further examine whether the effect of vitamin D supplementation on anemia risk varies by race/ethnicity, gender, or baseline levels of 25(OH)D.
Long-term Changes in Blood Protein Levels — 2 years
We will examine the samples from the 900 boston participants and determine whether vitamin D supplementation affects long-term changes in hemoglobin, red blood cell (RBC) indices, hepcidin, and erythropoietin (EPO) levels. These protein levels will be assessed in both anemic and non-anemic individuals in fresh samples at baseline \[pre-randomization\] and at 2 years of follow-up post-randomization.

Countries

United States