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Trial record 1 of 1 for:    NCT01835639
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Vitamin D Supplementation in Glomerular Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Children's Hospital of Philadelphia
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01835639
First received: April 17, 2013
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .

Condition Intervention
Glomerular Disease Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels. [ Time Frame: 12 weeks ]
  • 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:
  • 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 ]
  • To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1). [ Time Frame: 12 weeks ]
  • To assess arterial stiffness, measured by changes in pulse wave velocity. [ Time Frame: 12 weeks ]

Estimated Enrollment: 35
Study Start Date: April 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835639

Contacts
Contact: Maryjane F. Benton, BSN,RN,CCRC 267-648-3256 Benton@email.chop.edu

Locations
United States, Delaware
Nemours/Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Joshua Zaritsky, MD, PhD    302-651-5527    joshua.zaritsky@nemours.org   
Principal Investigator: Joshua Zaritsky, MD, PhD         
Principal Investigator: Christopher LaRosa, MD         
United States, Maryland
Johns Hopkins University,Division of Pediatric Nephrology Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, New York
North Shore-Long Island Jewish Health System Active, not recruiting
New Hyde Park, New York, United States, 11040
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maryjane F. Benton, BSN,RN,CCRC    267-648-3256    Benton@email.chop.edu   
Principal Investigator: Michelle Denburg, MD, MSCE         
The Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jonathan Hogan, MD    215-662-2638    Jonathan.Hogan2@uphs.upenn.edu   
Principal Investigator: Lawrence Holzman, MD         
Principal Investigator: Jonathan Hogan, MD         
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 )
Study First Received: April 17, 2013
Last Updated: July 28, 2017

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:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2017