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Vitamin D in Minorities With Prediabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876928
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : June 14, 2013
Last Update Posted : June 14, 2013
American Diabetes Association
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science

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

Condition or disease Intervention/treatment Phase
Pre-diabetes Drug: vitamin D Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population
Study Start Date : March 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percent of Subjects Who Develop Diabetes [ Time Frame: one year ]
    Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl

Secondary Outcome Measures :
  1. Disposition Index [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876928

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United States, California
Charles Drew University
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
American Diabetes Association
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Principal Investigator: Mayer B. Davidson, MD Charles Drew University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mayer Davidson, Professor of Medicine, Charles Drew University of Medicine and Science Identifier: NCT00876928    
Other Study ID Numbers: Vitamin D-Prediabetes
1-09-CR-15 ( Other Grant/Funding Number: American Diabetes Association )
First Posted: April 7, 2009    Key Record Dates
Results First Posted: June 14, 2013
Last Update Posted: June 14, 2013
Last Verified: April 2013
Keywords provided by Mayer Davidson, Charles Drew University of Medicine and Science:
oral glucose tolerance test
disposition index
insulin secretion
insulin sensitivity
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents