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Sponsors and Collaborators: |
Charles Drew University of Medicine and Science American Diabetes Association |
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Information provided by: | Charles Drew University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00876928 |
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Condition | Intervention |
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Pre-Diabetes |
Drug: vitamin D Drug: placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population |
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 |
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Placebo: Placebo Comparator
Subjects with low vitamin D levels and pre-diabetes
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Drug: placebo
medium chain triglyceride given once per week
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vitamin D: Experimental
Subjects with low vitamin D levels and pre-diabetes
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Drug: vitamin D
liquid vitamin D3 dissolved in medium chain triglyceride once a week
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Charles Drew University ( Mayer B. Davidson, MD ) |
Study ID Numbers: | Vitamin D-Prediabetes, 1-09-CR-15 |
Study First Received: | April 6, 2009 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00876928 History of Changes |
Health Authority: | United States: Institutional Review Board |
pre-diabetes minorities oral glucose tolerance test disposition index |
insulin secretion insulin sensitivity diabetes |
Cholecalciferol Metabolic Diseases Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases Trace Elements Bone Density Conservation Agents |
Insulin Hyperglycemia Vitamin D Vitamins Micronutrients Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Growth Substances Glucose Intolerance Physiological Effects of Drugs Diabetes Mellitus Prediabetic State Endocrine System Diseases |
Bone Density Conservation Agents Pharmacologic Actions Hyperglycemia Vitamin D Vitamins Micronutrients Glucose Metabolism Disorders |