Impact of Vitamin D on Diabetic Kidney Disease in African Americans

Status Completed

Clinical Trial Summary

This purpose of this project is to evaluate the effectiveness of vitamin D supplementation over 12 months in vitamin D deficient African American adults with type 2 diabetes.

Clinical Trial Description

Diabetic kidney disease is increasing in prevalence and is associated with significant morbidity and mortality. Health disparities exist in the progression of diabetic kidney disease, with minorities being more affected even when adjusting for treatment, glycemic and hypertensive control, and medical coverage. Secondary prevention of the progression of diabetic kidney disease is hindered by a lack of easily modifiable risk factors. Based on animal and observational human studies, vitamin D deficiency is potentially a novel, modifiable risk factor that may interrupt or delay the progression of diabetic kidney disease through direct effects as well as by helping to ameliorate kidney disease risk factors, such as hyperglycemia, hypertension and inflammation. In addition, based on minorities having a higher prevalence of vitamin D deficiency, it may also potentially impact the differential progression of diabetic kidney disease in minorities. However, clinical trials evaluating the impact of vitamin D supplementation on diabetic kidney disease are lacking. Thus, this pilot study funded as an R03 through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has the following specific aims: (1): To evaluate the impact of vitamin D supplementation (vitamin D3 at 400 IU/d versus 4000 IU/d) on the proportion of individuals with progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial. (2): To identify whether kidney disease risk factors such as blood pressure and glycemic control mediate the impact of vitamin D supplementation on the progression of albuminuria over 12 months in a sample of African American participants with vitamin D deficiency in a randomized controlled trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01214356
Study type	Interventional
Source	Medical University of South Carolina
Contact
Status	Completed
Phase	N/A
Start date	August 2010
Completion date	July 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.