The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults (AVIS)
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Purpose
Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, & insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar & blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.
The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Dietary Supplement: vitamin D3, cholecalciferol Dietary Supplement: Inactive comparator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults |
- Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 48 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vitamin D3 supplement
60,000 IU vitamin D3 oral supplement provided every four weeks at weeks 0, 4, 8, and 12 in the form of one 50,000 and two 5,000 IU vitamin D3 supplements in gelcap form.
|
Dietary Supplement: vitamin D3, cholecalciferol
1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.
|
|
Placebo Comparator: Sugar Pill
Inactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12.
|
Dietary Supplement: Inactive comparator
The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
|
Detailed Description:
Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.
Eligibility| Ages Eligible for Study: | 19 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- African American by self-report
- In good health
Exclusion Criteria:
- Diagnosis of diabetes
- Health problems/medication affecting calcium and/or vitamin D metabolism
- Current use of vitamin/mineral/herbal/nutritional supplements
- Inability to swallow pills
- Pregnancy
Contacts and Locations| United States, Georgia | |
| Medical College of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| Study Director: | Yanbin Dong, MD, PhD | Georgia Regents University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jennifer Pederson-White, DO, Medical College of Georgia |
| ClinicalTrials.gov Identifier: | NCT01141192 History of Changes |
| Other Study ID Numbers: | 0910091 |
| Study First Received: | June 4, 2010 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgia Regents University:
|
vitamin D status 25-OH D ionized calcium fasting glucose hemoglobin A1c fasting insulin glucose metabolism HOMA index blood lipids type 2 diabetes |
PTH adiposity body fat percentage dual energy x-ray absorptiometry pulse wave velocity arterial stiffness flow-mediated dilation African American inflammatory markers |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013