N/A
Completed N=117
Vitamin D in Minorities With Prediabetes
Pre-diabetes
Source: ClinicalTrials.gov NCT00876928 ↗
Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Percent of Subjects Who Develop Diabetes — 9; 12 percentage of participants — p=0.61
Summary
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Who Develop Diabetes |
9; 12 | 0.61 |
| SECONDARY Disposition Index |
1.4; 1.3; 1.5; 1.3; 1.4; 1.2 | 0.39 |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00876928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.