Overview

Status:Not yet recruiting
Keywords:Vitamin D , Idiopathic Nephrotic Syndrome
IRB Number:00057561
Specialty:Pediatric Nephrology
Sub Specialty:

Brief Summary

Study Design:  This is a prospective observational study of 53 children recruited from MWPNC centers with incident nephrotic syndrome designed to assess 25-vitamin D status.

SYNOPSIS: The primary goal of this study is to define the prevalence of 25-vitamin D deficiency at presentation and the association of 25-vitamin D relative to response to steroid therapy response patterns in children with incident idiopathic nephrotic syndrome.

Specific Aim 1: Evaluate the prevalence of 25-vitamin D deficiency in children at the time of diagnosis with idiopathic nephrotic syndrome

Hypothesis: At presentation patients will have a greater incidence of 25-vitamin D deficiency than the general population.

Specific Aim 2: Evaluate the association between the patterns of nephrotic syndrome treatment response and 25-vitamin D levels in children with incident nephrotic syndrome.

Hypothesis: 25-vitamin D levels will be lowest in treatment resistant patients compared with treatment responsive patients.

 

Principle Investigator: Raoul Nelson
Principle Department: Pediatric Administration
Co Investigator: Joseph Sherbotie
Co Investigator: Matt Grinsell

Contact Information

Name:JoAnn Narus
Phone:801-585-7497
Email:joann.narus@hsc.utah.edu

Inclusion Criteria

Inclusion Criteria: Patients should meet all inclusion criteria

-  Age 2-18 years old

-  New onset nephrotic syndrome

-  Urine protein/creatinine > 2mg/mg or urinalysis ≥ 2 + protein

-  Edema

-  ≤ 14 days of corticosteroid treatment

-  Informed consent is obtained

Exclusion Criteria

Exclusion Criteria:

  • Evidence of a disease process other than idiopathic nephrotic syndrome including hypocomplimentemia, positive Anti-nuclear antibody (>1:80), or systemic vasculitis

 

Rationale: The exclusion criteria are designed to avoid enrollment of patients with evidence of secondary nephrotic syndrome to remove any contributions systemic inflammation may introduce into 25-vitamin D deficiency.  Patients who have received  ≤ 14 days of steroids following a new diagnosis and are in remission are eligible for the study (this data will be collected and accounted for in the analysis.)

 

Definitions 1:

-          Remission: Urine protein/creatinine (mg/mg)  <0.2 or Albustix negative or trace for 3 days

-          Relapse: following remission, an increase in the first morning urine protein/creatinine (mg/mg) ≥ to 2 or Albustix ≥  2+ for 3 of 5 consecutive days

  • Steroid Dependent: relapse during taper or within 2 weeks of discontinuation of steroid therapy
  • Steroid Resistant: Inability to induce a remission with a minimum of 4 weeks of daily steroid therapy
  • Frequent relapsing: 2 or more relapses within 6 months after initial therapy or ≥ to 4 relapses in 12 months