Vitamin D in Minorities With Prediabetes

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Mayer Davidson, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00876928
First received: April 6, 2009
Last updated: April 17, 2013
Last verified: April 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

Resource links provided by NLM:


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 ]
    Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl


Secondary Outcome Measures:
  • Disposition Index [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better


Enrollment: 117
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876928

Locations
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
Investigators
Principal Investigator: Mayer B. Davidson, MD Charles Drew University
  More Information

No publications provided by Charles Drew University of Medicine and Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mayer Davidson, Professor of Medicine, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00876928     History of Changes
Other Study ID Numbers: Vitamin D-Prediabetes, 1-09-CR-15
Study First Received: April 6, 2009
Results First Received: July 3, 2012
Last Updated: April 17, 2013
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

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014