Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
Tracking Information | |||||
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First Received Date ICMJE | June 26, 2012 | ||||
Last Updated Date | October 1, 2012 | ||||
Start Date ICMJE | September 2010 | ||||
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incident type 2 diabetes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01633177 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes | ||||
Official Title ICMJE | Diabetes Prevention in the Vitamin D and Omega-3 Trial | ||||
Brief Summary | 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. |
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Detailed Description | Emerging evidence suggests favorable effects of both vitamin D and marine omega-3 fatty acids on glucose homeostasis. Optimal vitamin D intake is essential for insulin secretion and action, and omega-3 fatty acids may reduce diabetes risk as a result of favorable effects on insulin sensitivity, endothelial function, chronic inflammation, or other metabolic abnormalities. Although the metabolic effects of vitamin D and omega-3 fatty acids show considerable promise for the primary prevention of type 2 diabetes (T2D), there are no completed, ongoing, or planned randomized clinical trials of vitamin D or omega-3 supplements that include T2D as a primary outcome in a general population. We thus propose to utilize an NIH-funded randomized trial (1 U01 CA138962) to test the hypothesis that vitamin D and omega-3 supplementation will reduce the risk of T2D. We will further assess whether and to what extent vitamin D or omega-3 supplementation will improve insulin sensitivity and pancreatic beta-cell function in a subsample of the trial cohort. The VITamin D and OmegA-3 TriaL (VITAL) is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the benefits and risks of vitamin D3 (2,000 IU/day) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and cardiovascular disease (CVD). The VITAL trial will aim to enroll 20,000 men and women (aged ≥50 and ≥55 years, respectively). The planned treatment duration is 5 years after a 1.5-year recruitment period. This diabetes ancillary study aims to implement an inexpensive and efficient strategy to validate self-reported incident T2D cases in the entire trial population and to collect pre- and post-intervention measures of glucose, insulin, and hemoglobin A1c (HbA1c) in a subset of participants. Two methods of diabetes case validation are proposed. First, we plan to collect detailed information about diagnostic glucose testing and anti-diabetic medication use from medical records and/or supplementary questionnaires completed by the participant's physician. Second, to complement our diabetes ascertainment process, we will also plan to retrieve additional data on diabetes diagnoses and hypoglycemic medications by linking the participants with the Centers for Medicare and Medicaid Services (CMS) database. In addition to evaluating whether the study interventions impact the onset of clinical diabetes, we propose to collect pre- and post-intervention measures of glucose, insulin, and HbA1c in a subset of the participants to reliably assess whether vitamin D or omega-3 supplementation alters insulin and glucose homeostasis. We plan to recruit 1,000 participants without prior clinical diabetes at the Clinical and Translational Science Center (CTSC) site at Brigham and Women's Hospital. A standard 2-hour oral glucose tolerance test (OGTT) and HbA1c measurements will be performed during the CTSC visits at baseline and at 2-year post-randomization. Primary Aims:
Secondary Aims:
For the above main effect estimates, we will further explore whether the effect of vitamin D3 or EPA+DHA supplementation varies by (1) age, (2) sex, (3) baseline intakes of these nutrients, (4) baseline levels of 25(OH)D (for vitamin D3), (5) race/skin pigmentation (for vitamin D3), (6) geographic region (for vitamin D3), and (7) BMI (for vitamin D3). |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Type 2 Diabetes | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 1000 | ||||
Estimated Completion Date | June 2015 | ||||
Estimated Primary Completion Date | June 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study. |
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01633177 | ||||
Other Study ID Numbers ICMJE | 0308112690000, R01DK088078 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Yiqing Song, Brigham and Women's Hospital | ||||
Study Sponsor ICMJE | Brigham and Women's Hospital | ||||
Collaborators ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
Investigators ICMJE |
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Information Provided By | Brigham and Women's Hospital | ||||
Verification Date | October 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |