An interventional study of Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks in Glomerular Disease, sponsored by Children's Hospital of Philadelphia. Completed at 5 sites in United States. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Vitamin D
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
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
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia