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IRCT20231203060254N1 IRCT 2024-02-21 Tehran University of Medical Sciences Investigating the effect of zinc on pulmonary function in adults with cystic fibrosis Evalution the effect of zinc supplementation on pulmonary function in adults with cystic fibrosis in Imam Khomeini Hospital in 2023 , Randomize clinical trial 2024-01-09 anticipated 40 Complete https://irct.ir/trial/74948 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization We use allocation concealment, which refers to the method used to perform a random sequence on study participants, in such a way that the allocated group is not known before the allocation of the individual. By using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the envelopes in order are placed In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes is opened in order and assigned to a group. That participant is revealed, Blinding description: The trial is conducted in a triple-blind manner, so that the patient, the doctor, and the person who gives the medicine to the patients do not know the type of medicine so that the results can be judged. Patients are informed about the type of study and full treatment benefits. 3 Cystic fibrosis. Intervention 1: Intervention group: Clinical group 30 mg zinc tablets are given to patients daily. In the second group of patients, they have previously suffered from cystic fibrosis, which was diagnosed with genetic tests, and in both groups of patients, they did not mention a history of lung disease or cardiovascular disease. During the period of 3 months, regularly in the morning. The patients in the first group are given 30 mg zinc supplement. Intervention 2: Intervention group: They have a history of suffering from cystic fibrosis, which was confirmed by genetic tests that have already been done, and as a clinical group, 30 mg zinc tablets are given to patients daily. Intervention 3: Control group: Control group: In the second group, patients have previously suffered from cystic fibrosis, which has been diagnosed with genetic tests, and in both groups of patients, they do not mention a history of lung disease or cardiovascular disease. It is without zinc supplement, 1 pill is given daily and patients take the pill regularly for 3 months. Yes - There is a plan to make this available What will be shared: Spirometry results in patients When: Access starts 1 year after the results are ready To whom: Researchers in different universities of the world by presenting valid documents Conditions: It is sent in an analyzed form with a valid P value Where to obtain: To Dr. Rahman Dost and his email How to obtain: After viewing the identification documents and confirming the identity documents, the documents will be sent as soon as possible. Comments:
public Farzad rahmandost
No 12. Blv Keshavarz Tehran Province, Tehran, at the end of Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 fa_rdr@yahoo.com Tehran University of Medical Sciences scientific Farzad Rahman Dost
No 7 , Blv Keshavarz , Tehran Province, Tehran, at the end of Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 fa_rdr@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) They have a history of suffering from cystic fibrosis, which was confirmed by genetic tests that have been done before 18 years no limit Both E84 Cystic fibrosis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Clinical group 30 mg zinc tablets are given to patients daily. In the second group of patients, they have previously suffered from cystic fibrosis, which was diagnosed with genetic tests, and in both groups of patients, they did not mention a history of lung disease or cardiovascular disease. During the period of 3 months, regularly in the morning. The patients in the first group are given 30 mg zinc supplement Intervention group: They have a history of suffering from cystic fibrosis, which was confirmed by genetic tests that have already been done, and as a clinical group, 30 mg zinc tablets are given to patients daily. Control group: Control group: In the second group, patients have previously suffered from cystic fibrosis, which has been diagnosed with genetic tests, and in both groups of patients, they do not mention a history of lung disease or cardiovascular disease. It is without zinc supplement, 1 pill is given daily and patients take the pill regularly for 3 months. Spirometry test is performed and its results of fev1, fvc, RV, tlc are statistically compared in 2 groups. Timepoint: Finally after 3 months. Method of measurement: Spirometry. Tehran University of Medical Sciences Approved 2023-11-28 Imam Khominie Hospital NO 12. Tehran Province, Tehran, at the end of Keshavarz Blvd Imam Khominie Hospital NO 12. Tehran Province, Tehran, at the end of Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)