Status:
COMPLETED
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Glucose Intolerance
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- Diabetes requiring pharmacotherapy
- Smoking
- Hyperparathyroidism
- Hypercalcemia (Calcium \> 10.5 mg/dl)
- Kidney stone
- Pregnancy
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00436475
Start Date
September 1 2007
End Date
November 1 2009
Last Update
July 30 2019
Active Locations (1)
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1
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111