Comparing effect of two different prophylactic Vitamin D dosage on Bone Health in a child with Nephrotic Syndrome (1st Episode)

To compare the effect of two prophylactic Vitamin D regimen on Bone mineral health in Children with first episode Nephrotic syndrome - Open labelled Randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082823

Enrollment

Registered

2025-03-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes

Interventions

Intervention1: Vitamin D 600IU and Calcium 750mg: In Group A, Vitamin D dose will be 600 IU along with calcium 750 mg for 12 weeks (as first episode treatment is for 12 weeks)- To find out least possi

Eligibility

Inclusion criteria

Inclusion criteria: All Children between the ages of 1-12 years diagnosed as first episode Nephrotic syndrome.

Exclusion criteria

Exclusion criteria: 1. Children with clinical or biochemical evidence of Metabolic bone disease including vitamin D deficiency. 2. Children with pre-existing Chronic Liver Disease or Autoimmune Disorder. 3. Children with history of prolong steroids intake. 4. Children who develop resistance to steroids during the course of treatment.

Design outcomes

Primary

Measure	Time frame
1. Compare the proportionate change in Bone Mineral Density (Before and after the standard steroid therapy) in children with new onset nephrotic syndrome receiving vitamin D prophylaxis at a dose of 600 IU/day Vs 1000IU/day. 2. Compare the proportionate change in serum Calcium, Phosphate, Alkaline phosphatase, 25-OH vitamin D and serum Parathormone in children with new onset nephrotic syndrome receiving vitamin D prophylaxis at a dose of 600 IU/day Vs 1000IU/day.Timepoint: 1. Evaluation of Bone mineral density at the time of diagnosis (first episode nephrotic syndrome) and 4 weeks after completion of Treatment (6 weeks full dose steroids and 6 weeks alternate day steroids) 2. Evaluation of Biochemical parameters of Mineral bone disease at various time points of study. (Baseline, after 6 weeks of full dose steroids, after 6 weeks of alternate day steroids and after 4 weeks of treatment completion)	—

Measure

Time frame

1. Compare the proportionate change in Bone Mineral Density (Before and after the standard steroid therapy) in children with new onset nephrotic syndrome receiving vitamin D prophylaxis at a dose of 600 IU/day Vs 1000IU/day. 2. Compare the proportionate change in serum Calcium, Phosphate, Alkaline phosphatase, 25-OH vitamin D and serum Parathormone in children with new onset nephrotic syndrome receiving vitamin D prophylaxis at a dose of 600 IU/day Vs 1000IU/day.Timepoint: 1. Evaluation of Bone mineral density at the time of diagnosis (first episode nephrotic syndrome) and 4 weeks after completion of Treatment (6 weeks full dose steroids and 6 weeks alternate day steroids) 2. Evaluation of Biochemical parameters of Mineral bone disease at various time points of study. (Baseline, after 6 weeks of full dose steroids, after 6 weeks of alternate day steroids and after 4 weeks of treatment completion)

—

Secondary

Measure	Time frame
Prevalence of Vitamin D in Children with Nephrotic syndrome before starting steroids.Timepoint: At the beginning of study.	—

Countries

India

Contacts

Public ContactGirish Chandra Bhatt

AIIMS Bhopal

mahesh.pediatrics@aiimsbhopal.edu.in9425428596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026