Status:
COMPLETED
Vitamin D Supplementation in Glomerular Disease
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Society of Nephrology
Conditions:
Glomerular Disease
Eligibility:
All Genders
5-30 years
Phase:
NA
Brief Summary
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
Detailed Description
Vitamin D deficiency has been linked to a variety of adverse health outcomes. Nephrotic patients have very low vitamin D levels, and the underlying mechanisms are not known. Furthermore, approaches to...
Eligibility Criteria
Inclusion
- Males or females, age 5-30 years
- Diagnosis of primary glomerular disease (such as steroid-resistant nephrotic syndrome, minimal change disease, FSGS, membranous nephropathy, membranoprolfierative glomerulonephritis, and Immunoglobulin A \[IgA\] nephropathy) without systemic inflammatory disorders (i.e. lupus, vasculitis)
- Serum 25(OH)D level \<30 ng/ml and urine protein:creatinine ratio ≥0.5 at Screening Visit.
Exclusion
- Pregnancy
- estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73m2 at Screening Visit
- Serum phosphorus \> 5.5 mg/dl or hypercalcemia
- Chronic medical conditions or medications unrelated to the renal disease that may impact vitamin D status
- Known history of kidney stone(s)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01835639
Start Date
April 1 2013
End Date
September 1 2017
Last Update
August 12 2019
Active Locations (5)
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1
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
2
Johns Hopkins University,Division of Pediatric Nephrology
Baltimore, Maryland, United States, 21287
3
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104