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Vitamin D Supplementation in Glomerular Disease

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ClinicalTrials.gov Identifier: NCT01835639
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : August 12, 2019
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

Tracking Information
First Submitted Date  ICMJE April 17, 2013
First Posted Date  ICMJE April 19, 2013
Last Update Posted Date August 12, 2019
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • 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 ICal, Pi, and 25(OH)D, and urinary calcium excretion. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • To assess the innate immune response, measured by changes in the induction of hCAP in human monocytes. [ Time Frame: 12 weeks ]
  • To assess intra-renal inflammation, measured by changes in urinary MCP-1. [ Time Frame: 12 weeks ]
  • To assess arterial stiffness, measured by changes in pulse wave velocity. [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Glomerular Disease
Official Title  ICMJE Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glomerular Disease
Intervention  ICMJE Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Supplements will be provided as oral capsules.
Other Name: Vitamin D
Study Arms  ICMJE Experimental: Vitamin D Supplementation
Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Intervention: Dietary Supplement: Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2017)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)
35
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01835639
Other Study ID Numbers  ICMJE 12-009753
K23DK093556 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • American Society of Nephrology
  • The NephCure Foundation
Investigators  ICMJE
Principal Investigator: Michelle Denburg, MD, MSCE Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP