Vitamin D Supplementation in Glomerular Disease

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

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

Study Overview

• Status: Completed
• Conditions: Glomerular Disease
• Intervention / Treatment: Dietary supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Nemours/Alfred I. duPont Hospital for Children
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University,Division of Pediatric Nephrology
  • New York
    • New Hyde Park, New York, United States, 11040
      • North Shore-Long Island Jewish Health System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • The Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D Supplementation; Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks	Dietary supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks; Supplements will be provided as oral capsules.; Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Society of Nephrology; The NephCure Foundation
• Investigators: Principal Investigator: Michelle Denburg, MD, MSCE, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 19, 2013

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Vitamin D; Glomerular Disease; Steroid-resistant nephrotic syndrome; Minimal change disease; Focal segmental glomerulosclerosis (FSGS); Membranous Nephropathy; Membranoprolfierative Glomerulonephritis; immunoglobulin A (IgA) Nephropathy; FSGS; IgA Nephropathy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 12-009753; K23DK093556 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No