Status:
COMPLETED
Vitamin D in Minorities With Prediabetes
Lead Sponsor:
Charles Drew University of Medicine and Science
Collaborating Sponsors:
American Diabetes Association
Conditions:
Pre-diabetes
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Detailed Description
Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people wi...
Eligibility Criteria
Inclusion
- Age greater than 40.
- Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
- Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
- Serum 25-OHD less than 30 ng/ml
- Able and willing to provide informed consent
Exclusion
- FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
- Major psychiatric disorder on medication (excluding successfully treated depression)
- Diagnosed diabetes mellitus
- HIV/AIDS
- Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
- History of carcinoma, except skin basal cell or squamous cell skin carcinomas
- Heart failure, unstable angina or history of a myocardial infarction
- Alcohol or substance abuse
- Current treatment with glucocorticoids
- Current treatment with diabetes medications, including metformin
- Cushing's syndrome
- Primary hyperparathyroidism
- Nephrolithiasis
- Pregnancy or breast-feeding
- Regular visits to a tanning salon (unlikely in this minority population)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00876928
Start Date
March 1 2009
End Date
June 1 2012
Last Update
June 14 2013
Active Locations (1)
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1
Charles Drew University
Los Angeles, California, United States, 90059