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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
92
Vitamin D3 2,000 IU orally once daily
Calcium Carbonate 400 mg orally twice daily
Vitamin D3-Placebo
Tufts-New England Medical Center
Boston, Massachusetts, United States
Chang in Disposition Index, a Measure of Beta Cell Function
Range is 0 to infinity Lower is better.
Time frame: baseline and 4 months
Change in Hemoglobin A1c
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Time frame: Baseline to 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Calcium-Placebo