A study to compare two different doses of vitamin D supplementation in children with nephrotic syndrome

Comparative efficacy of two different doses of daily vitamin D supplementation in children with nephrotic syndrome: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009339

Enrollment

Registered

2017-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Oral Vitamin D in a dose of 1200 IU along with calcium 250-500 mg daily for 9-12 months: All eligible patients included in this study would be randomized to one of the two treatment all

Eligibility

Inclusion criteria

Inclusion criteria: All children in the age group of 1-14 years with nephrotic syndrome and having frequent relapses/steroid dependence

Exclusion criteria

Exclusion criteria: 1.Steroid resistant nephrotic syndrome/secondary nephrotic syndrome 2.Patients with other co-existing ailments which affect vitamin D levels, e.g. chronic or persistent diarrhea, chronic liver disease, or chronic kidney disease. 3.Children on long-term medications that affect vitamin D metabolism (except corticosteroids) such as anticonvulsants (phenobarbitone, phenytoin, carbamazepine, valproic acid), antifungals, antiretrovirals (ritononavir, sequinavir) 4.Patients not likely to follow-up or residing more than 100 Km form this hospital 5.Refusal to give consent

Design outcomes

Primary

Measure	Time frame
Mean change in serum 25(OH)-D levels in children with SDNS/ FRNSTimepoint: Before (baseline) and 9-12 months after supplementation of vitamin D	—

Secondary

Measure	Time frame
Frequency of vitamin D insufficiency and deficiency.Timepoint: At enrolment and at end of study;Mean change in serum levels of calcium, phosphorus, alkaline phosphatase, and PTH.Timepoint: At enrolment and at end of study;Relapse frequency, cumulative dose of steroids used, alternative medications needed and frequency of infections (clinical/laboratory confirmed episodes)Timepoint: At enrolment and at end of study	—

Measure

Time frame

Frequency of vitamin D insufficiency and deficiency.Timepoint: At enrolment and at end of study;Mean change in serum levels of calcium, phosphorus, alkaline phosphatase, and PTH.Timepoint: At enrolment and at end of study;Relapse frequency, cumulative dose of steroids used, alternative medications needed and frequency of infections (clinical/laboratory confirmed episodes)Timepoint: At enrolment and at end of study

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Countries

India

Contacts

Public ContactDr Kamran Afzal

Jawaharlal Nehru Medical College

rasmiya.mohiyadheen@gmail.com571-2721182

Outcome results

None listed

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