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
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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 |

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 |

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:
|
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
|
- Incident type 2 diabetes [ Time Frame: 5 years ]
- 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 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |

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
United States, Massachusetts | |
Division of Preventive Medicine, Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Yiqing Song, MD, ScD | Brigham and Women's Hospital |
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 |