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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01141192
Acronym
AVIS
Enrollment
48
Registered
2010-06-10
Start date
2010-01-31
Completion date
2010-05-31
Last updated
2010-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTvitamin 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_SUPPLEMENTInactive comparator

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

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Fasting glucose level before, mid-way through, and after the vitamin D3 supplement or placebo trial.16 weeks

Secondary

MeasureTime frame
Serum 25-OH D levels in response to vitamin D3 supplement or placebo across a range of adiposity16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026