Vitamin D Supplementation in Glomerular Disease

Glomerular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835639
• Other study ID #: 12-009753
• Secondary ID: K23DK093556
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: September 2017

Study information

• Verified date: August 2019
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glomerular Disease

Intervention

Dietary Supplement:
• Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Supplements will be provided as oral capsules.

Locations

Country	Name	City	State
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	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	American Society of Nephrology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The NephCure Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.		12 weeks
Primary	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	To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.		12 weeks
Secondary	To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).		12 weeks
Secondary	To assess arterial stiffness, measured by changes in pulse wave velocity.		12 weeks