Vitamin D Supplementation in Glomerular Disease

Study Overview
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Brief Summary
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This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .

Detailed Description
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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.

Official Title
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Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease

Conditions
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Glomerular Disease

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D Supplementation<br>Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks | Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks<br>* Supplements will be provided as oral capsules.<br>* Other names: Vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels. |  | 12 weeks | 
| To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes. |  | 12 weeks | 
| To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1). |  | 12 weeks | 
| To assess arterial stiffness, measured by changes in pulse wave velocity. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FSGS, Glomerular Disease, Vitamin D, Steroid-resistant nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis (FSGS), Membranous Nephropathy, Membranoprolfierative Glomerulonephritis, immunoglobulin A (IgA) Nephropathy, IgA Nephropathy