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

NCT01632761 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-11-21

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 .

DRUG

omega-3 fatty acids (fish oil)

DIETARY_SUPPLEMENT

Vitamin D3 placebo

DIETARY_SUPPLEMENT

Fish oil placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Office of Dietary Supplements (ODS)

    collaborator NIH

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Nancy Berliner, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2025-12-28
Completion
2025-12-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01632761 on ClinicalTrials.gov