Does treatemnt with Vitamin D and Calcium help patients with Steroid Sensitive Nephrotic Syndrome ?

Phase 4

Active, not recruiting

Conditions: Patients with Steroid Sensitive Nephrotic Syndrome in relapse at recruitment.

Registration Number: CTRI/2018/01/011225

Lead Sponsor: Institute of Child Health

Brief Summary: Steroid sensitive nephrotic syndrome (NS) is a common disease affecting Indian children. The majority of affected patients have multiple relapses over many years and require repeated and long term steroid courses. Steroid toxicities like osteoporosis have been well described in this condition and may cause long term morbidity, even after the NS has resolved. Reduction in bone mineralisation has been reported to occur early, within 2 to 3 months of steroid therapy. Unfortunately in the majority of patients steroid treatment cannot be avoided.

During NS episodes, there is loss of Vitamin D binding protein along with albumin in the urine. Patients have been shown to have low levels of 25 hydroxycholecalciferol in this condition. Correction of this associated hypovitaminosis D may improve bone health in this disease and reduce degree of osteoporosis.

In addition, low Vitamin D stores have been associated with inflammatory and infective conditions. Infections are the commonest precipitants of relapses in NS. Thus correction of hypovitaminosis D may reduce relapse rates in pediatric NS.

In this RCT, patients with NS relapse are recruited, and randomised into intervention and control groups. The intervention group receives Vitamin D and calcium supplements in the attempt to optimise serum 25hydroxycholecalciferol levels. Subsequently over a 6 month period, the changes in serum 25hydroxycholecalciferol, bone mineral density and bone mineral content as well as relapse rate is analysed and compared with the control group. Monitoring is performed for any adverse effects of Vitamin D therapy, such as hypercalcemia, hypercalciuria and nephrocalcinosis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 48

Inclusion Criteria

1.Patients with diagnosed steroid sensitive nephrotic syndrome 2.Age group: 2 to 14 years 3.Consecutive patients included during active NS episode 4.Urine protein more than 2+ for 3 consecutive days and urine protein creatinine ratio > 2 at recruitment.

Exclusion Criteria

1.Steroid Resistant nephrotic syndrome 2.Hospitalised patients 3.Any other acute or chronic illness 4.Patients with any bone deformities or symptoms related to the musculoskeletal system.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral content and density	at recruitment and post intervention after 6 months.

Secondary Outcome Measures

Name	Time	Method
Nephrotic Relapse rate	over 6 months
serum 25 hydroxycholecalciferol levels	at recruitment and post intervention 6 weeks and 6 months
Serum calcium and urinary calcium creatinine ratio	at recruitment and post intervention 6 weeks and 6 months
renal ultrasound	after 6 months

Trial Locations

Locations (1): Institute Of Child Health
🇮🇳
Kolkata, WEST BENGAL, India
Institute Of Child Health
🇮🇳Kolkata, WEST BENGAL, India
Dr Sushmita Banerjee
Principal investigator
9830023975
asban@vsnl.com