Vitamin D Supplementation in Glomerular Disease
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About
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
Full 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 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
32 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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