Trial Outcomes & Findings for Impact of Vitamin D on Diabetic Kidney Disease in African Americans (NCT NCT01214356)

Last Updated: 2018-10-16

Results Overview

Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2018-10-16

Participant Flow

Eligible if AA and Vitamin D Deficiency

eligibility criteria reviewed

Participant milestones

Participant milestones
Measure	Vitamin D Vitamin D supplementation	Usual Care vitamin D3 at 400 IU/d
Overall Study STARTED	27	27
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	17	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Vitamin D on Diabetic Kidney Disease in African Americans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D Supplementation n=27 Participants vitamin D3 at 4000 IU/d	Usual Care n=27 Participants vitamin D3 at 400 IU/d	Total n=54 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	53.4 years STANDARD_DEVIATION 10.7 • n=7 Participants	53.4 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Urinary Albumin:Creatinine Ratio (ACR) is a well-established, sensitive marker of nephropathy progression (urine albumin (mg/dL) to urine creatinine (g/dL) ratio).

Outcome measures

Outcome measures
Measure	Vitamin D Supplementation n=10 Participants vitamin D3 at 4000 IU/d	Usual Care n=13 Participants vitamin D3 at 400 IU/d
Change in Urinary Albumin:Creatinine Ratio (ACR)	-52.55555556 ratio Standard Deviation 151.8477372	46.44444444 ratio Standard Deviation 47.4125

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vanessa Diaz, MD MSCR

MUSC

Phone: 8438762923

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place