Proteinuria Clinical Trial
Official title:
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
Verified date | August 2023 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
Status | Completed |
Enrollment | 74 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18 years - Ability to provide informed consent - Chronic kidney disease stage 3 and 4 - On ACE inhibitor or ARB for albuminuria if tolerated - Assessed during eligibility screen: - Albuminuria >30 mg/g creatinine - 25(OH) vitamin D level >12.5 and <75 nmol/L Exclusion Criteria: - On vitamin D in past 4 weeks - Plans to relocate out of New York City in the next 6 months - 25 (OH) Vitamin D level <12.5 nmol/L - HIV infection - History of hypercalcemia or kidney stones - Serum phosphate >5.5 mg/dl in past 3 months - Serum calcium >10.0 mg/dl in past 3 months - SBP >160 DBP >100 at screening visit - Transplanted organ - Cancer - Polycystic kidney disease - Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore medical center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures. | Urine albumin and creatinine were measured on spot urine specimens. | 3 months | |
Secondary | Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome. | 25(OH) vitamin D levels were measured using liquid chromatography. | 3 months | |
Secondary | Effect of Vitamin D Supplementation on Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure in CKD Patients as a Secondary Outcome. | 3 months |
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