Diabetic Kidney Disease
Conditions
Keywords
diabetes, kidney disease, vitamin D
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTVitamin 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)
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Albumin:Creatinine Ratio (ACR) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Estimated Glomerular Filtration Rate (eGFR) | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible if AA and Vitamin D Deficiency
Pre-assignment details
eligibility criteria reviewed
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Supplementation vitamin D3 at 4000 IU/d | 27 |
| Usual Care vitamin D3 at 400 IU/d | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Vitamin D Supplementation | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 10.7 | 53.4 years STANDARD_DEVIATION 10.7 | 53.4 years STANDARD_DEVIATION 10.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 54 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 participants | 54 participants | 27 participants |
| Sex: Female, Male Female | 20 Participants | 41 Participants | 21 Participants |
| Sex: Female, Male Male | 7 Participants | 13 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 13 |
| other Total, other adverse events | 0 / 10 | 0 / 13 |
| serious Total, serious adverse events | 0 / 10 | 0 / 13 |
Outcome results
Primary
Change in Urinary Albumin:Creatinine Ratio (ACR)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Supplementation | Change in Urinary Albumin:Creatinine Ratio (ACR) | -52.55555556 ratio | Standard Deviation 151.8477372 |
| Usual Care | Change in Urinary Albumin:Creatinine Ratio (ACR) | 46.44444444 ratio | Standard Deviation 47.4125 |
Secondary
Decrease in Estimated Glomerular Filtration Rate (eGFR)
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