Vitamin D Supplementation in Glomerular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Glomerular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D Supplementation

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Supplements will be provided as oral capsules.

Interventions

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

Supplements will be provided as oral capsules.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vitamin D

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No