Vitamin D in Minorities With Prediabetes

Pre-diabetes Clinical Trial

Official title:

Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

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

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

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