Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
The VITamin D and OmegA-3 Trial (VITAL; NCT01169259) is a randomized clinical trial of
vitamin D (in the form of D3 [cholecalciferol]) and marine omega-3 fatty acid
(eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements in the primary
prevention of cancer and cardiovascular disease.
Eligible participants will be assigned by chance (like a coin toss) to one of four groups:
(1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily
vitamin D and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants have
an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of
getting at least one active agent.
Participants in all group will take two pills each day--one softgel that contains either
vitamin D3 or vitamin D placebo and one capsule that contains either omega-3 or omega-3
placebo. Participants will receive their study pills in convenient calendar packages via
Participants will also fill out a short (15-20 minute) questionnaire each year. The
questionnaire asks about health; lifestyle habits such as physical exercise, diet, and
smoking; use of medications and dietary supplements; family history of illness, and new
medical diagnoses. Occasionally participants may receive a phone call from study staff to
collect information or to clarify responses on the questions.
If a participant reports a new medical diagnosis of anemia on the short questionnaires, he
or she will be invited to participate in this sub-study. If the participant consents, his or
her medical record will be reviewed to confirm the diagnosis of anemia. We expect roughly
1,100 individuals to develop anemia while on the study.
Of the expected 20,000 participants in the VITAL trial, approximately 1,000 participants
will be seen in Boston and given the opportunity to participate in optional research blood
draws. This sub-study expects to receive approximately 10mL of the samples collected from
900 of these participants. This portion of blood will be used to evaluate the amount of
different proteins in both anemic and non-anemic individuals. Blood samples will be
collected at baseline and two years later.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Incidence of Anemia
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.
Nancy Berliner, MD
Brigham and Women's Hospital
United States: Institutional Review Board
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