| Descriptive Information Fields | |||||||||
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| Brief Title † | Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes | ||||||||
| Official Title † | Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes | ||||||||
| Brief Summary | The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes. |
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| Detailed Description | There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Insulin sensitivity, Insulin secretion and Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | glucose tolerance (fasting, after OGTT), systemic inflammation, lipoprotein profile, blood pressure, body weight and body composition [ Time Frame: 4 months ] [ Designated as safety issue: Yes ] Genetic studies on Vitamin D related genes and risk of type 2 diabetes and cardiometabolic outcomes [ Time Frame: 4 months ] [ Designated as safety issue: No ] To collect and archive biological specimens (serum, plasma, DNA) so that they can be used for testing of new hypotheses either within the parent stud or through future ancillary studies. [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ] |
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| Condition † | Glucose Intolerance Type 2 Diabetes Mellitus Metabolic Syndrome |
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| Intervention † | Drug: Vitamin D3 2,000 IU orally once daily Drug: Calcium Carbonate 400 mg orally twice daily Drug: Vitamin D3-Placebo Drug: Calcium-Placebo |
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| MEDLINE PMIDs | 17389701, 17277040, 16505521 | ||||||||
| Links | Related Info ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 112 | ||||||||
| Start Date † | September 2007 | ||||||||
| Completion Date | July 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Major Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00436475 | ||||||||
| Organization ID | DK76092 | ||||||||
| Secondary IDs †† | DK76092 | ||||||||
| Study Sponsor † | National Institutes of Health (NIH) | ||||||||
| Collaborators †† | Tufts Medical Center | ||||||||
| Investigators † |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||||||
| Verification Date | January 2009 | ||||||||
| First Received Date † | February 16, 2007 | ||||||||
| Last Updated Date | January 5, 2009 | ||||||||