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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06006689` - Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)	Phase 2
Enrolling by invitation	`NCT05530356` - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed	`NCT05086549` - An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria
Recruiting	`NCT05008276` - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Completed	`NCT02276196` - Effect of LIXIsenatide on the Renal System	Phase 4
Not yet recruiting	`NCT06120569` - Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients	N/A
Completed	`NCT02545049` - Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease	Phase 3
Active, not recruiting	`NCT02237352` - Mechanisms of Diabetic Nephropathy in Ecuador
Active, not recruiting	`NCT06176599` - Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis	N/A
Recruiting	`NCT03716401` - Prognostic Imaging Biomarkers for Diabetic Kidney Disease
Terminated	`NCT03840343` - Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease	Phase 1
Completed	`NCT01377688` - Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes	N/A
Active, not recruiting	`NCT05514548` - Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease	Phase 2
Recruiting	`NCT05507892` - Renal Mechanism of SGLT2 Inhibition	Phase 2
Not yet recruiting	`NCT06049550` - The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
Not yet recruiting	`NCT05514184` - Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease	N/A
Active, not recruiting	`NCT04589351` - Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe	Phase 3
Active, not recruiting	`NCT04531163` - Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy	Phase 2/Phase 3
Active, not recruiting	`NCT03620773` - Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes	Phase 1/Phase 2
Suspended	`NCT01878045` - Mechanisms of Diabetic Kidney Disease in American Indians

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.