- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876928
Vitamin D in Minorities With Prediabetes
April 17, 2013 updated by: Mayer Davidson, Charles Drew University of Medicine and Science
Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.
Study Overview
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
Interventional
Enrollment (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90059
- Charles Drew University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age greater than 40.
- Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
- Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
- Serum 25-OHD less than 30 ng/ml
- Able and willing to provide informed consent
Exclusion Criteria:
- FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
- Major psychiatric disorder on medication (excluding successfully treated depression)
- Diagnosed diabetes mellitus
- HIV/AIDS
- Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
- History of carcinoma, except skin basal cell or squamous cell skin carcinomas
- Heart failure, unstable angina or history of a myocardial infarction
- Alcohol or substance abuse
- Current treatment with glucocorticoids
- Current treatment with diabetes medications, including metformin
- Cushing's syndrome
- Primary hyperparathyroidism
- Nephrolithiasis
- Pregnancy or breast-feeding
- Regular visits to a tanning salon (unlikely in this minority population)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Subjects with low vitamin D levels and pre-diabetes
|
medium chain triglyceride given once per week
|
EXPERIMENTAL: vitamin D
Subjects with low vitamin D levels and pre-diabetes
|
liquid vitamin D3 dissolved in medium chain triglyceride once a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, 3, 6, 9, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mayer B. Davidson, MD, Charles Drew University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10.
- Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
April 6, 2009
First Submitted That Met QC Criteria
April 6, 2009
First Posted (ESTIMATE)
April 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 14, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vitamin D-Prediabetes
- 1-09-CR-15 (OTHER_GRANT: American Diabetes Association)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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