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Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Brigham and Women's Hospital
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: June 2, 2014
Last verified: June 2014
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Purpose
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 | 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 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 |
Resource links provided by NLM:
Further study details as provided by Yiqing Song, Brigham and Women's Hospital:
Primary Outcome Measures:
- Incident type 2 diabetes [ Time Frame: 5 years ]
Secondary Outcome Measures:
- OGTT index of insulin sensitivity [ Time Frame: 2 years ]
- OGTT index of beta-cell function [ Time Frame: 2 years ]
- HbA1c levels [ Time Frame: 2 years ]
| Enrollment: | 25875 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (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:
|
| 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:
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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01633177
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
| 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 ) |
| Study First Received: | June 26, 2012 |
| Last Updated: | June 2, 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 |
ClinicalTrials.gov processed this record on September 21, 2017