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Sponsors and Collaborators: |
National Institutes of Health (NIH) Tufts Medical Center |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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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 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes |
Estimated Enrollment: | 112 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
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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
|
2
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
|
Drug: Vitamin D3 2,000 IU orally once daily
Vitamin D3 2,000 IU orally once daily
Drug: Calcium-Placebo
Calcium-Placebo
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3
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
|
Drug: Calcium Carbonate 400 mg orally twice daily
Calcium Carbonate 400 mg orally twice daily
Drug: Vitamin D3-Placebo
Vitamin D3-Placebo
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4
Vitamin D3-Placebo plus Calcium-Placebo
|
Drug: Vitamin D3-Placebo
Vitamin D3-Placebo
Drug: Calcium-Placebo
Calcium-Placebo
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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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Age
BMI
Glucose Intolerance / Mild Diabetes defined as
Major Exclusion Criteria:
Contact: Marie Francia, MD | 617-636-2834 | caddm@tufts-nemc.org |
Contact: Anastassios Pittas, MD | 617-636-2834 | caddm@tufts-nemc.org |
United States, Massachusetts | |
Tufts-New England Medical Center | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Marie Francia, MD 617-636-2834 caddm@tufts-nemc.org | |
Contact: Noah Lubowsky, MD 617-636-2834 caddm@tufts-nemc.org | |
Principal Investigator: Anastassios G Pittas, MD MS | |
Sub-Investigator: Bess Dawson-Hughes, MD | |
Sub-Investigator: Frank Hu, MD PhD |
Principal Investigator: | Anastassios G Pittas, MD MS | Tufts Medical Center |
Responsible Party: | Tufts-New England Medical Center ( Anastassios G. Pittas ) |
Study ID Numbers: | DK76092, DK76092 |
Study First Received: | February 16, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00436475 |
Health Authority: | United States: Federal Government |
Glucose intolerance Type 2 diabetes mellitus Metabolic syndrome |
Cholecalciferol Metabolic Diseases Glucose Intolerance Diabetes Mellitus Ergocalciferols Endocrine System Diseases Calcium Carbonate |
Calcium, Dietary Hyperglycemia Vitamin D Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins Syndrome |
Physiological Effects of Drugs Antacids Bone Density Conservation Agents Micronutrients Pharmacologic Actions |