Vitamin D Supplementation in Glomerular Disease
August 9, 2019 updated by: Children's Hospital of Philadelphia
Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease
This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Nemours/Alfred I. duPont Hospital for Children
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University,Division of Pediatric Nephrology
-
-
New York
-
New Hyde Park, New York, United States, 11040
- North Shore-Long Island Jewish Health System
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, United States, 19104
- The Hospital of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vitamin D Supplementation
Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks
|
Supplements will be provided as oral capsules.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.
Time Frame: 12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12 weeks
|
|
To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).
Time Frame: 12 weeks
|
12 weeks
|
|
To assess arterial stiffness, measured by changes in pulse wave velocity.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michelle Denburg, MD, MSCE, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
April 17, 2013
First Submitted That Met QC Criteria
April 17, 2013
First Posted (Estimate)
April 19, 2013
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 9, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-009753
- K23DK093556 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.