Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/21/2018 |
| Start Date: | November 2012 |
| End Date: | June 2019 |
Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
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.
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.
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 U.S.
mail.
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.
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 U.S.
mail.
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.
Participants in VITAL (NCT 01169259) who do not have anemia at baseline and who report a
diagnosis of anemia on the VITAL follow-up questionnaires are eligible to participate in
this ancillary study.
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