Comparison of the efficacy of two dosing regimens of Vitamin D for bone protection in children with difficult nephrotic syndrome
Phase 3
- Conditions
- Health Condition 1: null- having nephrotic syndrome
- Registration Number
- CTRI/2016/10/007405
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Children ( >1 year) with difficult nephrotic syndrome (FRNS, SDNS and SRNS), attending pediatric nephrology clinic and pediatric inpatient department, JIPMER
Exclusion Criteria
i)Children with history of hypocalcemic seizures, tetany, rickets or fractures. ii)Known cases of renal stones.
iii)Children on phenytoin, phenobarbitone, methotrexate, furosemide, thiazides or bisphosphonates.
iv)Chronic renal failure or chronic liver disease.
v)Secondary causes of NS (e. g IgA nephropathy, Henoch Schonlein Purpura nephritis, Lupus nephritis)
vi)Children already taking vitamin D.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in Bone Mineral Content (BMC) in children with difficult nephrotic syndrome treated with 400 IU per day versus 1000 IU per day of Vitamin D supplementation during a one-year follow up periodTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method Secondary outcome variables (BMD, serum calcium, phosphate, alkaline phosphatase, iPTH)Timepoint: 12 months