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Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (CaDDM)
This study is currently recruiting participants.
Study NCT00436475.   Last updated on January 5, 2009.
Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
This Tabular View shows the required WHO registration data elements as marked by

Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Insulin sensitivity, Insulin secretion and Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
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 ]
Glucose Intolerance
Type 2 Diabetes Mellitus
Metabolic Syndrome
Drug: Vitamin D3 2,000 IU orally once daily
Drug: Calcium Carbonate 400 mg orally twice daily
Drug: Vitamin D3-Placebo
Drug: Calcium-Placebo
17389701,   17277040,   16505521
Related Info This link exits the ClinicalTrials.gov site
 
Recruiting
112
September 2007
July 2010

Inclusion Criteria:

  • Ethnicity: all ethnic groups
  • Gender: men and women
  • Age

    1. Lower age limit: 40 years inclusive
    2. Upper age limit: NONE
  • BMI

    1. Lower BMI limit: 25 inclusive
    2. Upper BMI limit: 40 inclusive
  • Glucose Intolerance / Mild Diabetes defined as

    1. Fasting glucose ≥100 mg/dl OR
    2. 2-hr glucose after OGTT ≥140 mg/dl OR
    3. 5.8 ≤ Hemoglobin A1c ≤ 7

Major Exclusion Criteria:

  • Diabetes requiring pharmacotherapy
  • Smoking
  • Hyperparathyroidism
  • Hypercalcemia (Calcium > 10.5 mg/dl)
  • Kidney stone
  • Pregnancy
Both
40 Years and older
Yes
Contact: Marie Francia, MD 617-636-2834 caddm@tufts-nemc.org
Contact: Anastassios Pittas, MD 617-636-2834 caddm@tufts-nemc.org
United States
 
NCT00436475
DK76092
DK76092
National Institutes of Health (NIH)
Tufts Medical Center
Principal Investigator: Anastassios G Pittas, MD MS Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2009
February 16, 2007
January 5, 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.