Status:Not yet recruiting
Keywords:Vitamin D , Idiopathic Nephrotic Syndrome
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.
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
- ≤ 14 days of corticosteroid treatment
- Informed consent is obtained
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.)
- 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