Clinical trial NCT01835639: Vitamin D Supplementation in Glomerular Disease
Official title: Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glomerular Disease
Keywords: 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
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: American Society of Nephrology
name: The NephCure Foundation
First posted: 2013-04-19
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
timeFrame: 12 weeks
measure: To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion.
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes.
timeFrame: 12 weeks
measure: To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).
timeFrame: 12 weeks
measure: To assess arterial stiffness, measured by changes in pulse wave velocity.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Baltimore
country: United States
facility: Johns Hopkins University,Division of Pediatric Nephrology
state: Maryland
city: New Hyde Park
country: United States
facility: North Shore-Long Island Jewish Health System
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Michelle Denburg, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: