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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Nancy Berliner, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01632761
First received: June 29, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Anemia
Dietary Supplement: Vitamin D3 .
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Incidence of Anemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Long-term Changes in Blood Protein Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of Anemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Long-term Changes in Protein Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil
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)
Active Comparator: Vitamin D + fish oil placebo
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
Active Comparator: Vitamin D placebo + fish oil

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
Active Comparator: Vitamin D placebo + fish oil placebo
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

Detailed Description:

The VITamin D and OmegA-3 Trial (VITAL; NCT01169259) is a randomized clinical trial of vitamin D (in the form of D3 [cholecalciferol]) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) supplements in the primary prevention of cancer and cardiovascular disease.

Eligible participants will be assigned by chance (like a coin toss) to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants have an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.

Participants in all group will take two pills each day--one softgel that contains either vitamin D3 or vitamin D placebo and one capsule that contains either omega-3 or omega-3 placebo. Participants will receive their study pills in convenient calendar packages via U.S. mail.

Participants will also fill out a short (15-20 minute) questionnaire each year. The questionnaire asks about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and new medical diagnoses. Occasionally participants may receive a phone call from study staff to collect information or to clarify responses on the questions.

If a participant reports a new medical diagnosis of anemia on the short questionnaires, he or she will be invited to participate in this sub-study. If the participant consents, his or her medical record will be reviewed to confirm the diagnosis of anemia. We expect roughly 1,100 individuals to develop anemia while on the study.

Of the expected 20,000 participants in the VITAL trial, approximately 1,000 participants will be seen in Boston and given the opportunity to participate in optional research blood draws. This sub-study expects to receive approximately 10mL of the samples collected from 900 of these participants. This portion of blood will be used to evaluate the amount of different proteins in both anemic and non-anemic individuals. Blood samples will be collected at baseline and two years later.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632761

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Nancy Berliner, MD Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Nancy Berliner, Chief, Hematology Division, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01632761     History of Changes
Other Study ID Numbers: 2012P001526
Study First Received: June 29, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by Brigham and Women's Hospital:
anemia
vitamin D3
omega-3 fatty acids
fish oil
primary prevention

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014