Investigating the effect of Q10 on laboratory findings in thalassemia patients treated with deferasirox: a double-blind clinical trial

The aim of the present study is to investigate the effect of Q10 on laboratory findings in thalassemia patients treated with deferasirox.

This study is a double-blind parallel clinical trial with a 3-month intervention period, in which people are divided into two groups of 43 people randomly using Randomized Allocation Software.

This study will be conducted at Shahid Mohammadi Hospital and Aburihan Bandar Abbas Center affiliated with Hormozgan University of Medical Sciences. After explaining the study to the patient and obtaining informed consent, the patients are placed in one group and the treatment begins. At the beginning and at the end of the study (3 months later), 10 cc of blood and urine tests were also performed to check the effectiveness of the treatment. In this study, blinding will be done for participants, personnel, and researchers. In this way, drugs and placebo will be placed in the same packages by a person outside the study.

Patients with major and intermedia beta-thalassemia disease; patients who have had a history of taking Deferasirox regularly in the past three months, if they wish to cooperate (consent form will be completed by the parents of the patients for children under 18 years old and the patients themselves for patients over 18 years old).

Group 1) 100 mg of ketones will be given daily for 3 months to thalassemia patients treated with Deferasirox. Group 2) Placebo pill (100mg) which does not contain an interfering agent, was given daily for 3 months to thalassemia patients treated with Deferasirox will be given.

Determining the effectiveness of intervention after treatment using laboratory parameters (urea, creatinine, GFR, uric acid, pr/cr ratio) Using a biochemistry autoanalyzer device

Due to the fact that most adult thalassemia patients take multiple drugs at the same time and most children take only one medication, we reduced the age of entering the study. Kiton medicine is not contraindicated for people over one year of age.

Before starting the study, all participants will be explained that they will be divided into two intervention (A) and control (B) groups. In this trial, we had two groups of 4 blocks (including 2 participants in drug group A and 2 participants in placebo group B). Production tools are also used from random sequence generation software (random allocation software) that this sequence generation software gives items that are able to generate a random sequences by block building method on simple structures. Blocked randomization is for the purpose of making sure that precisely equal number of participants are included in the intervention and control group at consecutive but equal time intervals. The randomization process is done by methodology consultant and the clinical researchers are not aware of the randomization method. Concealment Allocation refers to the method used to perform a random sequence on participants in the study, in such a way that the allocated group is not known before the allocation of the individual. By using opaque and sealed envelopes with a random sequence (Sequentially numbered, seal, 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 They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box.

In this study, blinding will be done for participants and researchers. In this way, the medicine and placebo will be placed in the same packages by a person outside the study, which will be labeled with A and B codes. The given codes will be provided to researchers after statistical analysis and when writing the article. To blind the participants and reduce their bias, it was explained to them only at the beginning of the study that they will receive one of two types of intervention and they will not be told the exact type of supplement.

the data will be collected by the colleagues participating in the project

6 month

corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade,

Only for data collection and analysis

corresponding Author: Dr. Parvin Kamkar, Dr. Malihe Mohammad zade

Written request and request of the project manager and main collaborators (Dr. Parvin Kamkar, Dr. Malihe Mohammad zade, Dr. Ebrahim Eftekhar, Narjes Seddighi)