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

The aim of this study is to determine and compare the effects of vitamin A and Corticosteroid on the healing of scar tissue in patients with acute pyelonephritis.

Study design: a parallel double-blind clinical trial (both patients and researchers) with a control group and in phase 3, with a sample size of 60 people, will be conducted on three groups of 20 patients with acute pyelonephritis, the first group being treated with vitamin A and the second group will be treated with corticosteroids. The third group also receives a placebo. In this study, the allocation of people to groups is done randomly with the help of ten blocks of letters A, B, C and using the Random Allocation software.

In the Nephrology Clinic of Imam Reza Hospital, Kermanshah, 60 eligible acute pyelonephritis patients are evaluated at the beginning of the study and 6 months later .

Inclusion criteria included diagnosis of acute pyelonephritis and hospitalization, children aged 3 months to 6 years, positivity of all urine cultures and exclusion criteria including lack of consent to participate in the study, neurogenic bladder, obstructive uropathy, intolerance Vitamin A and symptoms of vitamin A poisoning such as bad breath, hypotension, hypertension, apnea.

Study intervention: Patients will be assigned to three groups to receive vitamin D (n=20), Corticosteroid (n=20) or placebo (n=20). Vials of vitamin D, Corticosteroid and placebo are similar in shape, color, and size.

The main outcome is the change in the severity of the kidney scar, which is evaluated by a nuclear scan at the beginning and end of the sixth month of the study.

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.

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.