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

N/A

Waitlist Available

Led By Nancy Berliner, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Summary

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.

Eligible Conditions

Anemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Long-term Changes in Blood Protein Levels

Secondary study objectives

Incidence of Anemia

Long-term Changes in Protein Levels

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups

Active Control

Group I: Vitamin D + fish oilActive Control2 Interventions

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Drug: omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Group II: Vitamin D + fish oil placeboActive Control2 Interventions

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Dietary Supplement: Fish oil placebo Fish oil placebo

Group III: Vitamin D placebo + fish oil placeboActive Control2 Interventions

Dietary Supplement:Vitamin D3 placebo Vitamin D placebo Dietary Supplement: Fish oil placebo Fish oil placebo

Group IV: Vitamin D placebo + fish oilActive Control2 Interventions

Drug: omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]). Dietary Supplement: Vitamin D3 placebo Vitamin D placebo

0 / 1Eligibility criteria met