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IRCT20180519039715N5 IRCT 2023-04-16 Kermanshah University of Medical Sciences Investigating the effect of vitamin A and coronet in the treatment of kidney scar Investigating the effect of vitamin A and Corticosteroid in reducing renal scarring in patients with acute pyelonephritis: a double-blind randomized clinical trial study with a control group 2023-05-05 anticipated 60 Complete https://irct.ir/trial/69353 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are placed in three equal groups (drug A, C, B) based on a randomized table with 10 blocks designed using Random allocation software (with one-to-one allocation). In order to randomly assign 60 patients to three groups, first, 6 blocks of 10 different letters A, C, and B are created, which respectively indicate the group treated with vitamin A, B the group treated with corticosteroids, and C the placebo group. Then these blocks were numbered with numbers one to six. In the next step, each of these blocks is randomly selected by drawing 6 times from numbers one to six. In this way, in each lottery, by choosing a block, a combination of 10 letters A (group treated with vitamin A), B (group treated with cortone) and C (placebo group) is obtained, and at the end of the 6 stages of the lottery Drawing, after selecting 6 blocks, a total of 6 combinations of 10 letters A and C B will be obtained. The combination obtained from the letters A, C, and B are placed individually in 6 separate envelopes and sealed, and one envelope is opened with each patient's visit to determine which group the patient belongs to take, Blinding description: Given that the drug and placebo are identical in terms of shape, color, smell, size, and packaging, participants, researchers, or outcome assessors will be unaware of study group allocation. 3 Acute pyelonephritis. Intervention 1: Intervention group: Receiving vitamin A, manufactured by Osoeh Pharmaceutical Company of Iran, by injection during three days of hospitalization, three times in three days, and each injection of 25,000 units for children under one year and 50,000 units for children one year and older. Intervention 2: Intervention group:receiving corticosteroid (dexamethasone), manufactured by Tehran Shimi Pharmaceutical Company of Iran, by injection during three days of hospitalization, daily (0.15 mg/kg/day) in two divided doses. Intervention 3: Control group: receiving placebo (normal saline), produced by the Faculty of Pharmacy of Kermanshah University of Medical Sciences, by injection during three days of hospitalization, daily (0.15 mg/kg/day) in two divided doses. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to not starting to collect patient data
public Mehrnoush Mohamadi Kamalvand
Bagh Abrisham Blvd, Imam reza hospital
Kermanshah Iran (Islamic Republic of) 6719851451 +98 83 3826 4513 mehrnooshmohammadi.k1367@gmail.com Kermanshah University of Medical Sciences scientific sayed abolhasane sayedzadeh
Bagh Abrisham Blvd, Imam reza hospital
Kermanshah Iran (Islamic Republic of) 6719851451 +98 83 3826 4513 asayedzadeh@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Diagnosis of acute pyelonephritis and hospitalization. Children aged 3 months to 6 years, All urine cultures are positive. 3 months 6 years Both Lack of consent to participate in the study, neurogenic bladder, obstructive uropathy, Vitamin A intolerance, Symptoms of vitamin A poisoning, N11.0 Nonobstructive reflux-associated chronic pyelonephritis Treatment - Drugs Treatment - Drugs Placebo Intervention group: Receiving vitamin A, manufactured by Osoeh Pharmaceutical Company of Iran, by injection during three days of hospitalization, three times in three days, and each injection of 25,000 units for children under one year and 50,000 units for children one year and older. Intervention group:receiving corticosteroid (dexamethasone), manufactured by Tehran Shimi Pharmaceutical Company of Iran, by injection during three days of hospitalization, daily (0.15 mg/kg/day) in two divided doses. Control group: receiving placebo (normal saline), produced by the Faculty of Pharmacy of Kermanshah University of Medical Sciences, by injection during three days of hospitalization, daily (0.15 mg/kg/day) in two divided doses. Change in severity of kidney scar. Timepoint: The beginning of the study (before the intervention), 6 months after the intervention. Method of measurement: by dimercaptosuccinic acid (DMSA) scan. Kermanshah University of Medical Sciences Approved 2023-01-08 Ethics Committee of Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermansha Kermanshah Kermanshah Iran (Islamic Republic of)