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

NCT01141192 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-06-10

No results posted yet for this study

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.

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

Inactive comparator

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

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Yanbin Dong, MD, PhD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01141192 on ClinicalTrials.gov