Vitamin D Supplementation in Glomerular Disease

• ClinicalTrials.gov Identifier: NCT01835639
• Recruitment Status: Completed
• First Posted: April 19, 2013
• Last Update Posted: August 12, 2019
• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Society of Nephrology; The NephCure Foundation
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Glomerular Disease	Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
• Study Start Date: April 2013
• Actual Primary Completion Date: September 2017
• Actual Study Completion Date: September 2017

Arms and Interventions

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 Name: Vitamin D

Outcome Measures

Primary Outcome Measures :

1. To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels. [ Time Frame: 12 weeks ]
2. 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 Outcome Measures :

1. 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 ]
2. To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1). [ Time Frame: 12 weeks ]
3. To assess arterial stiffness, measured by changes in pulse wave velocity. [ Time Frame: 12 weeks ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Delaware

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States, 19803

United States, Maryland

Johns Hopkins University,Division of Pediatric Nephrology

Baltimore, Maryland, United States, 21287

United States, New York

North Shore-Long Island Jewish Health System

New Hyde Park, New York, United States, 11040

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Children's Hospital of Philadelphia

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

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT01835639 History of Changes
• Other Study ID Numbers: 12-009753; K23DK093556 ( U.S. NIH Grant/Contract )
• First Posted: April 19, 2013
• Last Update Posted: August 12, 2019
• Last Verified: August 2019

Keywords provided by Children's Hospital of Philadelphia:

Glomerular Disease; Vitamin D; 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:

Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents