Vitamin D in Minorities With Prediabetes
Recruitment status was Recruiting
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Purpose
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
| Condition | Intervention |
|---|---|
|
Pre-Diabetes |
Drug: vitamin D Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population |
- Percent of subjects who develop diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
- Disposition index [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 186 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Subjects with low vitamin D levels and pre-diabetes
|
Drug: placebo
medium chain triglyceride given once per week
|
|
Experimental: vitamin D
Subjects with low vitamin D levels and pre-diabetes
|
Drug: vitamin D
liquid vitamin D3 dissolved in medium chain triglyceride once a week
|
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 with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Mayer B. Davidson, MD | 323 357-3439 | mayerdavidson@cdrewu.edu |
| Contact: Petra Duran, BS | 323 357-3428 | petraduran@cdrewu.edu |
| United States, California | |
| Charles Drew University | Recruiting |
| Los Angeles, California, United States, 90059 | |
| Contact: Petra Duran, BS 323-357-3428 petraduran@cdrewu.edu | |
| Contact: Mayer B. Davidson, MD 323 357-3439 mayerdavidson@cdrewu.edu | |
| Sub-Investigator: Theodore C. Friedman, MD, PhD | |
| Principal Investigator: | Mayer B. Davidson, MD | Charles Drew University |
More Information
No publications provided by Charles Drew University of Medicine and Science
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mayer B. Davidson, MD, Charles Drew University |
| ClinicalTrials.gov Identifier: | NCT00876928 History of Changes |
| Other Study ID Numbers: | Vitamin D-Prediabetes, 1-09-CR-15 |
| Study First Received: | April 6, 2009 |
| Last Updated: | April 6, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Charles Drew University of Medicine and Science:
|
pre-diabetes minorities oral glucose tolerance test disposition index |
insulin secretion insulin sensitivity diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Intolerance Prediabetic State Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperglycemia Vitamin D |
Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013