Vitamin D Supplementation in Glomerular Disease



Status:Suspended
Conditions:Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:5 - 30
Updated:8/10/2018
Start Date:April 2013
End Date:July 2019

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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. .

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.

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)
We found this trial at
5
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Lawrence Holzman, MD
Phone: 215-662-2638
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Michelle Denburg, MD, MSCE
Phone: 267-648-3256
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Baltimore, Maryland 21287
Principal Investigator: Meredith A. Atkinson, M.D., M.H.S.
Phone: 443-287-9043
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New Hyde Park, New York 11040
Principal Investigator: Christine Sethna, MD, EdM
Phone: 718-470-3493
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New Hyde Park, NY
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Wilmington, Delaware 19803
Principal Investigator: Joshua Zaritsky, MD, PhD
Phone: 302-651-5527
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Wilmington, DE
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