← Back to Search

Omega-3 Fatty Acid

Vitamin D + fish oil for 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

Study 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.

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term Changes in Blood Protein Levels
Secondary outcome measures
Incidence of Anemia
Long-term Changes in Protein Levels

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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,612 Previous Clinical Trials
11,468,575 Total Patients Enrolled
2 Trials studying Anemia
132 Patients Enrolled for Anemia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,849,048 Total Patients Enrolled
101 Trials studying Anemia
16,294 Patients Enrolled for Anemia
Office of Dietary Supplements (ODS)NIH
52 Previous Clinical Trials
52,447 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~161 spots leftby Apr 2025