Vitamin D in Minorities With Prediabetes

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charles Drew University of Medicine and Science
• Collaborator: American Diabetes Association
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Age greater than 40.

2. Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or

3. Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)

4. Serum 25-OHD less than 30 ng/ml

5. Able and willing to provide informed consent

Exclusion Criteria:

1. FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl

2. Major psychiatric disorder on medication (excluding successfully treated depression)

3. Diagnosed diabetes mellitus

4. HIV/AIDS

5. Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder

6. History of carcinoma, except skin basal cell or squamous cell skin carcinomas

7. Heart failure, unstable angina or history of a myocardial infarction

8. Alcohol or substance abuse

9. Current treatment with glucocorticoids

10. Current treatment with diabetes medications, including metformin

11. Cushing's syndrome

12. Primary hyperparathyroidism

13. Nephrolithiasis

14. Pregnancy or breast-feeding

15. Regular visits to a tanning salon (unlikely in this minority population)