Nephrotic Syndrome. Nephrotic syndrome
Conditions
Interventions
Patients in this group will receive oral calcitriol in addition to standard therapy for nephrotic syndrome.Calcitriol is the active form of vitamin D3, chemically known as 1,25 dihydroxyvitamin D3.• N
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: Children aged 1 to 18 years Diagnosis of nephrotic syndrome confirmed by a pediatric nephrologist History of at least one documented relapse of nephrotic syndrome Steroid sensitive nephrotic syndrome Currently in remission at the time of enrollment Ability to take oral medications Written informed consent obtained from parents or legal guardians
Exclusion criteria
Exclusion criteria: Steroid resistant nephrotic syndrome Secondary nephrotic syndrome Congenital nephrotic syndrome Chronic kidney disease stage 3 or higher Hypercalcemia or known disorders of calcium metabolism Current use of vitamin D or calcitriol supplementation Known hypersensitivity or contraindication to calcitriol Presence of severe systemic or chronic disease interfering with study participation Refusal or inability of parents or legal guardians to provide written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate of nephrotic syndrome, defined as the number of relapse episodes with proteinuria of 3+ or 4+ for at least three consecutive days during the follow-up period. Timepoint: At baseline and then monthly throughout the 24-month follow-up during scheduled monthly visits; laboratory assessments are performed at baseline and at months 6, 12, 18, and 24. Method of measurement: Relapse of nephrotic syndrome is defined and recorded based on the presence of proteinuria of 3+ or 4+ on urine dipstick testing for at least three consecutive days. Clinical assessments are performed monthly throughout the 24-month follow-up period, and laboratory evaluations are conducted at baseline and at months 6, 12, 18, and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of any adverse events related to calcitriol use that are recorded and reported during the 24-month follow-up period. Laboratory tests are performed at baseline and at months 6, 12, 18, and 24. Timepoint: Measurement time points: At baseline (before the start of intervention), and then at 6, 12, 18, and 24 months after the start of intervention. Method of measurement: Adverse events related to calcitriol use, including hypercalcemia, are assessed using blood laboratory tests. These tests include measurement of total serum calcium and ionized serum calcium levels in venous blood samples. In addition, serum creatinine level is measured to monitor kidney function, and serum phosphorus level is measured as part of the metabolic profile related to calcitriol use. All laboratory tests are performed according to the standard protocol of the Children’s Medical Center laboratory using automated biochemical analyzers, such as photometry-based or ion-selective electrode-based systems. Results are recorded and reported as numerical values using standard units, including milligrams per deciliter for calcium and phosphorus and milligrams per deciliter for creatinine. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMastaneh Moghtaderi
Tehran University of Medical Sciences
Outcome results
None listed