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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00876928
Other study ID # Vitamin D-Prediabetes
Secondary ID 1-09-CR-15
Status Completed
Phase N/A
First received April 6, 2009
Last updated April 17, 2013
Start date March 2009
Est. completion date June 2012

Study information

Verified date April 2013
Source Charles Drew University of Medicine and Science
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 117
Est. completion date June 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
vitamin D
liquid vitamin D3 dissolved in medium chain triglyceride once a week
placebo
medium chain triglyceride given once per week

Locations

Country Name City State
United States Charles Drew University Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Charles Drew University of Medicine and Science American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent of Subjects Who Develop Diabetes Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl one year No
Secondary Disposition Index Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better Baseline, 3, 6, 9, 12 months No
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