Vitamin D Supplementation in Glomerular Disease

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01835639

Enrollment

Registered

2013-04-19

Start date

2013-04-30

Completion date

2017-09-30

Last updated

2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glomerular Disease

Keywords

Glomerular Disease, Vitamin D, Steroid-resistant nephrotic syndrome, Minimal change disease, Focal segmental glomerulosclerosis (FSGS), Membranous Nephropathy, Membranoprolfierative Glomerulonephritis, immunoglobulin A (IgA) Nephropathy, FSGS, IgA Nephropathy

Brief summary

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

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.

Interventions

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

Supplements will be provided as oral capsules.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 30 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Secondary

Measure	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).	12 weeks
To assess arterial stiffness, measured by changes in pulse wave velocity.	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026