Vitamin D Supplementation in Glomerular Disease

Children's Hospital of Philadelphia32 enrolled

Overview

This 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glomerular Disease

Interventions

Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeksDIETARY_SUPPLEMENT

Supplements will be provided as oral capsules.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 30 Years

Medical Language ↔ Plain English

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)

Locations (5)

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

Johns Hopkins University,Division of Pediatric Nephrology

Baltimore, Maryland, United States

North Shore-Long Island Jewish Health System

New Hyde Park, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.

Time frame: 12 weeks

To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.

Time frame: 12 weeks

Secondary Outcomes

To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.

Time frame: 12 weeks

To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).

Time frame: 12 weeks

To assess arterial stiffness, measured by changes in pulse wave velocity.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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