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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK093556 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| American Society of Nephrology | OTHER |
| The NephCure Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Supplementation | Experimental | Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks | Dietary Supplement | Supplements will be provided as oral capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels. | 12 weeks | |
| To assess the safety of vitamin D supplementation, by serum Ionized calcium (ICal), Pi, and 25(OH)D, and urinary calcium excretion. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the innate immune response, measured by changes in the induction of Human cathelicidin antimicrobial protein (hCAP) in human monocytes. | 12 weeks | |
| To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Denburg, MD, MSCE | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Johns Hopkins University,Division of Pediatric Nephrology |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| D009402 | Nephrosis, Lipoid |
| D005923 | Glomerulosclerosis, Focal Segmental |
| D015433 | Glomerulonephritis, Membranous |
| D007674 | Kidney Diseases |
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 12 weeks |
| To assess arterial stiffness, measured by changes in pulse wave velocity. | 12 weeks |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| North Shore-Long Island Jewish Health System | New Hyde Park | New York | 11040 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |