Anemia Clinical Trial
Official title:
Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
Verified date | January 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 2000 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI), Office of Dietary Supplements (ODS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Primary | Long-term Changes in Blood Protein Levels | 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. | 2 years | |
Secondary | Incidence of Anemia | We will compare the number of participants taking fish oil supplements who developed anemia and the number of participants not taking fish oil supplements who developed anemia to the current rates of development of anemia in the U.S. We will also study the number participants diagnosed with anemia over 4 years of follow-up and whether the effect of taking fish oil supplements on anemia risk varies by race/ethnicity, gender, or baseline levels of omega-3 fatty acid. | 2 years | |
Secondary | Long-term Changes in Protein Levels | We will examine the samples collected from the 900 Boston participants and determine whether fish oil 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. | 2 years |
Status | Clinical Trial | Phase | |
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