Evalution the effect of zinc supplementation on pulmonary function in adults with cystic fibrosis in Imam Khomeini Hospital in 2023 , Randomize clinical trial

Investigating the effect of zinc supplementation on pulmonary function

Clinical trial with a control group, with parallel groups, double-blind, randomized

In the implementation method of this plan, which is done in the form of a clinical trial, all patients referred to the CF clinic are examined. Then, the entry and exit criteria of the patients are entered and randomly divided into 2 groups receiving zinc supplement or placebo with the help of a computerized random number table. As a 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

The first group has a history of 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. 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 any history of lung disease or cardiovascular disease.

During the period of 3 months, the patients in the first group are given 30 mg of zinc supplement regularly in the mornings, and in the second group, a placebo with the same form but without zinc supplement is given 1 daily and regularly during 3 months.

Finally, after 3 months, a spirometry test is performed on the patients and the results of fev1, fvc, RV, tlc are statistically compared in 2 groups.

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

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.

Spirometry results in patients

Access starts 1 year after the results are ready

Researchers in different universities of the world by presenting valid documents

It is sent in an analyzed form with a valid P value

To Dr. Rahman Dost and his email

After viewing the identification documents and confirming the identity documents, the documents will be sent as soon as possible.