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OpenTrials
Completed

NCT Number: NCT01141192

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

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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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Georgia

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D3, cholecalciferol

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.

Inactive comparator

Dietary Supplement

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

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

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

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Acronym: AVIS

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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