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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yiqing Song, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01633177
First received: June 26, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 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 Intervention
Type 2 Diabetes
 Dietary Supplement: Vitamin D3
Drug: Omega-3 fatty acid (fish oil)
Dietary Supplement: Vitamin D3 placebo
Drug: Fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diabetes Prevention in the Vitamin D and Omega-3 Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Incident type 2 diabetes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • OGTT index of insulin sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • OGTT index of beta-cell function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • HbA1c levels [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 26, 2012
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013