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The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults (AVIS)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D3, cholecalciferol
Inactive comparator
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring 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

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Georgia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3 supplement

Sugar Pill

Arm Description

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.

Inactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12.

Outcomes

Primary Outcome Measures

Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.

Secondary Outcome Measures

Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity

Full Information

First Posted
June 4, 2010
Last Updated
June 9, 2010
Sponsor
Augusta University
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1. Study Identification

Unique Protocol Identification Number
NCT01141192
Brief Title
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
Acronym
AVIS
Official Title
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Augusta University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 supplement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Inactive placebo tablets identical in appearance to the active comparator provided every four weeks at weeks 0,4,8,and 12.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3, cholecalciferol
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inactive comparator
Intervention Description
The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
Primary Outcome Measure Information:
Title
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanbin Dong, MD, PhD
Organizational Affiliation
Augusta University
Official's Role
Study Director
Facility Information:
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19106328
Citation
Liu E, Meigs JB, Pittas AG, McKeown NM, Economos CD, Booth SL, Jacques PF. Plasma 25-hydroxyvitamin d is associated with markers of the insulin resistant phenotype in nondiabetic adults. J Nutr. 2009 Feb;139(2):329-34. doi: 10.3945/jn.108.093831. Epub 2008 Dec 23.
Results Reference
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PubMed Identifier
20304061
Citation
Pittas AG, Dawson-Hughes B. Vitamin D and diabetes. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):425-9. doi: 10.1016/j.jsbmb.2010.03.042. Epub 2010 Mar 18.
Results Reference
background
PubMed Identifier
18846051
Citation
Voidonikola PT, Stamatelopoulos KS, Alevizaki M, Kollias GE, Zakopoulos NA, Lekakis JP, Anastasiou E, Theodorakis MJ, Pittas AG, Papamichael CM. The association between glycemia and endothelial function in nondiabetic individuals: the importance of body weight. Obesity (Silver Spring). 2008 Dec;16(12):2658-62. doi: 10.1038/oby.2008.431. Epub 2008 Oct 9.
Results Reference
background
PubMed Identifier
20392893
Citation
Liu E, Meigs JB, Pittas AG, Economos CD, McKeown NM, Booth SL, Jacques PF. Predicted 25-hydroxyvitamin D score and incident type 2 diabetes in the Framingham Offspring Study. Am J Clin Nutr. 2010 Jun;91(6):1627-33. doi: 10.3945/ajcn.2009.28441. Epub 2010 Apr 14.
Results Reference
background
PubMed Identifier
21986705
Citation
Zhu H, Guo D, Li K, Pedersen-White J, Stallmann-Jorgensen IS, Huang Y, Parikh S, Liu K, Dong Y. Increased telomerase activity and vitamin D supplementation in overweight African Americans. Int J Obes (Lond). 2012 Jun;36(6):805-9. doi: 10.1038/ijo.2011.197. Epub 2011 Oct 11.
Results Reference
derived

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The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults

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