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Impact of Vitamin D on Diabetic Kidney Disease in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Medical University of South Carolina.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01214356
First received: October 1, 2010
Last updated: June 13, 2011
Last verified: October 2010
  Purpose

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.


Condition Intervention
Diabetic Kidney Disease
Drug: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Vitamin D on Diabetic Kidney Disease in African Americans

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Progression of Kidney Disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression. We will calculate an average urine albumin (mg/dL) to urine creatinine (g/dL) ratio based on three first-morning spot collections. ACR will be measured by a turbidimetric method using SYNCHRON® System every 6 months. An increase in a subject's mean ACR will be considered an indicator of disease progression.


Secondary Outcome Measures:
  • Decrease in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Estimated Glomerular Filtration Rate (eGFR) will be evaluated every 6 months, since changes in eGFR and ACR may occur independently and represent different pathways to the development of renal insufficiency. eGFR will be calculated via the Modification of Diet in Renal Disease (MDRD) equation of 4 variables (Cr level, age, sex, race) per NKF recommendations, with serum creatinine (Cr) measured using the SYNCHRON® System by means of the Jaffe rate method. For the purposes of this study, a decrease in eGFR will serve as a secondary outcome measure.


Estimated Enrollment: 102
Study Start Date: February 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lower Dose Vitamin D
Vitamin D3 supplementation of 400 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day
Drug: Vitamin D3
Patients receive vitamin D 400 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
Other Name: Cholecalciferol
Active Comparator: Higher Dose Vitamin D
Vitamin D3 supplementation of 4000 IU/D or 4000 IU/D with combined calcium carbonate supplementation of 1000 mg/day
Drug: Vitamin D3
Patients receive vitamin D 4000 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
Other Name: Cholecalciferol

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American race
  • Diagnosis of Type 2 Diabetes
  • Stage 1 or 2 Kidney Disease with detectable microalbuminuria >4.0 (mg/g) 25(OH)D level <20 ng/ml

Exclusion Criteria:

  • Type 1 diabetes

    --> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis

  • Unable to provide informed consent or contact information
  • Pre-existing calcium or parathyroid condition, including serum calcium >10.2 mg/dL
  • Sarcoidosis, active tuberculosis, or malignancy
  • Known hypersensitivity to vitamin D or any of its analogues and derivatives
  • Current pregnancy or planning to become pregnant in next 15 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214356

Contacts
Contact: Vanessa A Diaz, MD, MS 843-792-7241 diazva@musc.edu
Contact: Tara M Hogue 843-792-0800 hoguetm@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vanessa A Diaz, MD, MS    843-792-7241    diazva@musc.edu   
Contact: Tara M Hogue    843-792-0800    hoguetm@musc.edu   
Sub-Investigator: Arch G Mainous, PhD         
Sub-Investigator: Bruce Hollis, PhD         
Sub-Investigator: Carol Wagner, MD         
Sub-Investigator: Amy H Wahlquist, PhD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Vanessa A Diaz, MD, MS Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Vanessa Diaz, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01214356     History of Changes
Other Study ID Numbers: 1R03DK089120
Study First Received: October 1, 2010
Last Updated: June 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
diabetes
kidney disease
vitamin D

Additional relevant MeSH terms:
Ergocalciferols
Vitamin D
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urologic Diseases
Calcium Carbonate
Cholecalciferol
Vitamins
Antacids
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014