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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

vitamin D3, cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

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.

Sugar Pill

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

Group Type PLACEBO_COMPARATOR

Inactive comparator

Intervention Type DIETARY_SUPPLEMENT

The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Inactive comparator

The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No