Vitamin D Supplementation in Glomerular Disease

Not Applicable

Completed

• Conditions: Glomerular Disease
• Interventions: Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

• Registration Number: NCT01835639
• Lead Sponsor: Children's Hospital of Philadelphia

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 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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-19
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D Supplementation	Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks	Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

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

The Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States