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

NCT01632761 | Active Not Recruiting DMC

• 1 other identifier: 2012P001526
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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

Anemia

Keywords

anemia; vitamin D3; omega-3 fatty acids; fish oil; primary prevention

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Incidence of Anemia

  2 years

• Long-term Changes in Protein Levels

  2 years

Study Arms (4)

Vitamin D + fish oil

ACTIVE COMPARATOR

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 \[DHA\]).

Dietary Supplement: Vitamin D3 .; Drug: omega-3 fatty acids (fish oil)

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3 .; Dietary Supplement: Vitamin D3 placebo

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

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

Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil placebo

ACTIVE COMPARATOR

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

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

Interventions

Vitamin D3 . DIETARY_SUPPLEMENT

Vitamin D + fish oil; Vitamin D + fish oil placebo

omega-3 fatty acids (fish oil) DRUG

Vitamin D + fish oil; Vitamin D placebo + fish oil

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

Fish oil placebo DIETARY_SUPPLEMENT

Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Office of Dietary Supplements (ODS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Welcome to the VITAL study website

MeSH Terms

Conditions

Anemia

Interventions

Cholecalciferol; Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Oils

Study Officials

• Nancy Berliner, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Hematology Division

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 3, 2012
• Study Start: November 1, 2012
• Primary Completion: December 28, 2025
• Study Completion: December 28, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)