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Vitamin D in Minorities With Prediabetes
This study is currently recruiting participants.
Verified by Charles Drew University of Medicine and Science, April 2009
First Received: April 6, 2009   No Changes Posted
Sponsors and Collaborators: Charles Drew University of Medicine and Science
American Diabetes Association
Information provided by: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00876928
  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

MedlinePlus related topics: Diabetes Dietary Supplements
Drug Information available for: Vitamin D
U.S. FDA Resources
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

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Percent of subjects who develop diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: Placebo Comparator
Subjects with low vitamin D levels and pre-diabetes
Drug: placebo
medium chain triglyceride given once per week
vitamin D: Experimental
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
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876928

Contacts
Contact: Mayer B. Davidson, MD 323 357-3439 mayerdavidson@cdrewu.edu
Contact: Petra Duran, BS 323 357-3428 petraduran@cdrewu.edu

Locations
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            
Sponsors and Collaborators
Charles Drew University of Medicine and Science
American Diabetes Association
Investigators
Principal Investigator: Mayer B. Davidson, MD Charles Drew University
  More Information

No publications provided

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

Keywords provided by Charles Drew University of Medicine and Science:
pre-diabetes
minorities
oral glucose tolerance test
disposition index
insulin secretion
insulin sensitivity
diabetes

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009