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Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (CaDDM)

This study has been completed.
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00436475
First received: February 16, 2007
Last updated: March 15, 2011
Last verified: March 2011
History of Changes

February 16, 2007
March 15, 2011
September 2007
November 2009   (final data collection date for primary outcome measure)
Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Insulin sensitivity, Insulin secretion and Disposition Index at 4 months
Complete list of historical versions of study NCT00436475 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity, Insulin secretion, 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 tolerance, systemic inflammation at 4 months
Not Provided
Not Provided
 
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Glucose Intolerance
  • Type 2 Diabetes Mellitus
  • Metabolic Syndrome
  • Drug: Vitamin D3 2,000 IU orally once daily
    Vitamin D3 2,000 IU orally once daily
  • Drug: Calcium Carbonate 400 mg orally twice daily
    Calcium Carbonate 400 mg orally twice daily
  • Drug: Vitamin D3-Placebo
    Vitamin D3-Placebo
  • Drug: Calcium-Placebo
    Calcium-Placebo
  • 1
    Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
    Interventions:
    • Drug: Vitamin D3 2,000 IU orally once daily
    • Drug: Calcium Carbonate 400 mg orally twice daily
  • 2
    Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
    Interventions:
    • Drug: Vitamin D3 2,000 IU orally once daily
    • Drug: Calcium-Placebo
  • 3
    Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
    Interventions:
    • Drug: Calcium Carbonate 400 mg orally twice daily
    • Drug: Vitamin D3-Placebo
  • 4
    Vitamin D3-Placebo plus Calcium-Placebo
    Interventions:
    • Drug: Vitamin D3-Placebo
    • Drug: Calcium-Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
November 2009
November 2009   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00436475
DK76092 (completed), DK76092
Yes
Anastassios G. Pittas, Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Dietary Supplements (ODS)
Tufts Medical Center
Principal Investigator: Anastassios G Pittas, MD MS Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP