Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (CaDDM)
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Purpose
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 |
|---|---|---|
|
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes |
- Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- 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 ]
| Estimated Enrollment: | 112 |
| Study Start Date: | September 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
|
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
|
|
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
|
|
4
Vitamin D3-Placebo plus Calcium-Placebo
|
Drug: Vitamin D3-Placebo
Vitamin D3-Placebo
Drug: Calcium-Placebo
Calcium-Placebo
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ethnicity: all ethnic groups
- Gender: men and women
Age
- Lower age limit: 40 years inclusive
- Upper age limit: NONE
BMI
- Lower BMI limit: 25 inclusive
- Upper BMI limit: 40 inclusive
Glucose Intolerance / Mild Diabetes defined as
- Fasting glucose ≥100 mg/dl OR
- 2-hr glucose after OGTT ≥140 mg/dl OR
- 5.8 ≤ Hemoglobin A1c ≤ 7
Major Exclusion Criteria:
- Diabetes requiring pharmacotherapy
- Smoking
- Hyperparathyroidism
- Hypercalcemia (Calcium > 10.5 mg/dl)
- Kidney stone
- Pregnancy
Contacts and Locations| United States, Massachusetts | |
| Tufts-New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Anastassios G Pittas, MD MS | Tufts Medical Center |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anastassios G. Pittas, Tufts Medical Center |
| ClinicalTrials.gov Identifier: | NCT00436475 History of Changes |
| Other Study ID Numbers: | DK76092 (completed), DK76092 |
| Study First Received: | February 16, 2007 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Glucose intolerance Type 2 diabetes mellitus Metabolic syndrome |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Intolerance Metabolic Syndrome X Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia Insulin Resistance Hyperinsulinism Calcium, Dietary Cholecalciferol |
Vitamin D Ergocalciferols Calcium Carbonate Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013