We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01835639
Previous Study | Return to List | Next Study

Vitamin D Supplementation in Glomerular Disease

This study has suspended participant recruitment.
(slow accrual and Investigators seek to evaluate the study status and data)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01835639
First Posted: April 19, 2013
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 ]

Enrollment: 32
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835639


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 Submitted: April 17, 2013
First Posted: April 19, 2013
Last Update Posted: November 8, 2017
Last Verified: November 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