Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00876928
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : June 14, 2013
Last Update Posted : June 14, 2013
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Results First Submitted Date  ICMJE July 3, 2012
Results First Posted Date  ICMJE June 14, 2013
Last Update Posted Date June 14, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Percent of Subjects Who Develop Diabetes [ Time Frame: one year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
Disposition Index [ Time Frame: one year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D in Minorities With Prediabetes
Official Title  ICMJE Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population
Brief Summary Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pre-diabetes
Intervention  ICMJE
  • Drug: vitamin D
    liquid vitamin D3 dissolved in medium chain triglyceride once a week
  • Drug: placebo
    medium chain triglyceride given once per week
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Subjects with low vitamin D levels and pre-diabetes
    Intervention: Drug: placebo
  • Experimental: vitamin D
    Subjects with low vitamin D levels and pre-diabetes
    Intervention: Drug: vitamin D
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2013)
117
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2009)
186
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00876928
Other Study ID Numbers  ICMJE Vitamin D-Prediabetes
1-09-CR-15 ( Other Grant/Funding Number: American Diabetes Association )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayer Davidson, Charles Drew University of Medicine and Science
Study Sponsor  ICMJE Charles Drew University of Medicine and Science
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Mayer B. Davidson, MD Charles Drew University
PRS Account Charles Drew University of Medicine and Science
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP