Title
Vitamin D Supplementation in Glomerular Disease
Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
Phase
N/ALead Sponsor
University of PennsylvaniaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Glomerular DiseaseIntervention/Treatment
vitamin d3 ...Study Participants
32This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
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 safely and effectively supplement vitamin D in these patients have not been established. The purpose of this research study is to learn if vitamin D supplementation is safe and effective in patients with primary glomerular disease and to also help establish the treatment guidelines. About 35 patients with primary glomerular disease, ages 5-30 years old, will take part in this study. Participants will be asked to take vitamin D supplements each day for 12 weeks and will have 3 study visits.
Supplements will be provided as oral capsules.
Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Inclusion Criteria: 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 Criteria: 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)
