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Completed

NCT Number: NCT01835639

Vitamin D Supplementation in Glomerular Disease

This multi-site, pilot study will assess vitamin D supplementation in children and young adults with Glomerular Disease. .

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Key information

Age range

5 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks

Dietary Supplement

Supplements will be provided as oral capsules.

Other names: Vitamin D

Primary outcomes

  1. To assess the efficacy of vitamin D supplementation, by the increase in total and free 25(OH)D levels.

    Time frame: 12 weeks

  2. 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

Secondary outcomes

  1. 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

  2. To assess intra-renal inflammation, measured by changes in urinary Macrophage chemo-attractant protein 1 (MCP-1).

    Time frame: 12 weeks

  3. To assess arterial stiffness, measured by changes in pulse wave velocity.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • American Society of Nephrology
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The NephCure Foundation

Registry information

Official study title

Pilot Study: Efficacy and Safety of Vitamin D Supplementation in Glomerular Disease

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2013
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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