Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
NCT Number: NCT00436475
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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Notify Me40 year and older
All sexes
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02111, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Major Exclusion Criteria:
Vitamin D3 2,000 IU orally once daily
Calcium Carbonate 400 mg orally twice daily
Vitamin D3-Placebo
Calcium-Placebo
Time frame: baseline and 4 months
Range is 0 to infinity Lower is better.
Time frame: Baseline to 4 months
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Tufts Medical Center
Other
Acronym: CaDDM
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