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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Ages Eligible for Study:	50 Years and older (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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