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Impact of Vitamin D on Diabetic Kidney Disease in African Americans

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ClinicalTrials.gov Identifier: NCT01214356
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetic Kidney Disease
Intervention Dietary Supplement: Vitamin D3
Enrollment 54
Recruitment Details Eligible if AA and Vitamin D Deficiency
Pre-assignment Details eligibility criteria reviewed
Arm/Group Title Vitamin D Usual Care
Hide Arm/Group Description Vitamin D supplementation vitamin D3 at 400 IU/d
Period Title: Overall Study
Started 27 27
Completed 10 13
Not Completed 17 14
Arm/Group Title Vitamin D Supplementation Usual Care Total
Hide Arm/Group Description vitamin D3 at 4000 IU/d vitamin D3 at 400 IU/d Total of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
53.4  (10.7) 53.4  (10.7) 53.4  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
20
  74.1%
21
  77.8%
41
  75.9%
Male
7
  25.9%
6
  22.2%
13
  24.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
 100.0%
27
 100.0%
54
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title Change in Urinary Albumin:Creatinine Ratio (ACR)
Hide Description Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin D Supplementation Usual Care
Hide Arm/Group Description:
vitamin D3 at 4000 IU/d
vitamin D3 at 400 IU/d
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: ratio
-52.55555556  (151.8477372) 46.44444444  (47.4125)
2.Secondary Outcome
Title Decrease in Estimated Glomerular Filtration Rate (eGFR)
Hide Description 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.
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D Supplementation Usual Care
Hide Arm/Group Description vitamin D3 at 4000 IU/d vitamin D3 at 400 IU/d
All-Cause Mortality
Vitamin D Supplementation Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D Supplementation Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D Supplementation Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Vanessa Diaz, MD MSCR
Organization: MUSC
Phone: 8438762923
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01214356     History of Changes
Other Study ID Numbers: 1R03DK089120 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2010
First Posted: October 5, 2010
Results First Submitted: August 23, 2018
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018