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Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes

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ClinicalTrials.gov Identifier: NCT01633177
Recruitment Status : Unknown
Verified June 2014 by Yiqing Song, Brigham and Women's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yiqing Song, Brigham and Women's Hospital

Study Description
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Brief Summary:
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 U.S. men and women investigating 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 nondiabetic participants in VITAL and will examine whether vitamin D or fish oil prevent type 2 diabetes. Findings from this proposed study conducted within the VITAL trial will clarify whether vitamin D and omega-3 fatty acid supplementation reduces risk of type 2 diabetes and thus will inform public health and clinical guidelines for diabetes prevention.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Vitamin D3 Drug: Omega-3 fatty acid (fish oil) Dietary Supplement: Vitamin D3 placebo Drug: Fish oil placebo Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25875 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diabetes Prevention in the Vitamin D and Omega-3 Trial
Study Start Date : September 2010
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Vitamin D and Omega-3 Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol

Drug: Omega-3 fatty acid (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]).
Other Names:
  • fish oil
  • eicosapentaenoic acid
  • docosahexaenoic acid
  • EPA
  • DHA
  • Omacor®
Active Comparator: Vitamin D and Omega-3 placebo Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol

Drug: Fish oil placebo
Fish oil placebo
Active Comparator: Vitamin D placebo and Omega-3 Drug: Omega-3 fatty acid (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]).
Other Names:
  • fish oil
  • eicosapentaenoic acid
  • docosahexaenoic acid
  • EPA
  • DHA
  • Omacor®

Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo
Placebo Comparator: Vitamin D placebo and Omega-3 placebo Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo

Drug: Fish oil placebo
Fish oil placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incident type 2 diabetes [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. OGTT index of insulin sensitivity [ Time Frame: 2 years ]
  2. OGTT index of beta-cell function [ Time Frame: 2 years ]
  3. HbA1c levels [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633177


Locations
United States, Massachusetts
Division of Preventive Medicine, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Yiqing Song, MD, ScD Brigham and Women's Hospital
More Information
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Responsible Party: Yiqing Song, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01633177     History of Changes
Other Study ID Numbers: 0308112690000
R01DK088078 ( U.S. NIH Grant/Contract )
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Yiqing Song, Brigham and Women's Hospital:
vitamin D
omega-3 fatty acids
Type 2 diabetes
 Oral glucose tolerance test (OGTT)
Insulin sensitivity
Beta-cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Vitamin D
 Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents