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

Sponsor

Augusta University (Other)

Overall Status

Completed

CT.gov ID

NCT01141192

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

12.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: vitamin D3, cholecalciferol Dietary Supplement: Inactive comparator	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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