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IRCT20201129049534N6 IRCT 2021-09-16 Esfahan University of Medical Sciences Evaluation of the effect of selenium on patients with thyroid cancer treated with radioactive iodine Evaluation of the effect of selenium supplementation on sonographic findings of salivary glands and inflammatory factors and oxidative stress in patients with thyroid cancer treated with radioactive iodine 2021-10-06 anticipated 60 Complete https://irct.ir/trial/58522 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website: https://www.sealedenvelope.com/simple-randomiser/v1/lists), Blinding description: The study will be double blinded so that the researcher and the subjects will not know which group they belong to. For blinding, selenium and placebo capsules are prepared in the same shape, color and size. These capsules are coded by someone other than the researchers (A and B) and then the capsules are given to patients. Until the end of the study and after analyzing the data, researchers will not know about the intervention and control groups. 2 Thyroid cancer. Intervention 1: Intervention group: Patients receiving a selenium capsule containing 200 micrograms of selenium per day for 10 days (3 days before treatment with radioactive iodine to 6 days after treatment with radioactive iodine). Intervention 2: Control group: Patients receiving a placebo capsule containing 200 micrograms of maltodextrin per day for 10 days (3 days before radioactive iodine treatment to 6 days after radioactive iodine treatment). Yes - There is a plan to make this available What will be shared: Study information will be published after the individuals are unidentified and after the project is completed. When: Access period starts six months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For further analysis Where to obtain: Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir How to obtain: After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided Comments:
public Mohammad Bagherniya
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3972 3138 bagherniya@nutr.mui.ac.ir Esfahan University of Medical Sciences scientific Bijan Iraj
Hezar-jerib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 bijaniraj@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Ages 20 to 65 Diagnosis of thyroid cancer by imaging, such as ultrasound, computed tomography, magnetic resonance imaging, and positron tomography (PET) scan 20 years 65 years Both History of sialadenitis (inflammation of the salivary glands) Sjogren's history History of collagen vascular disease involving the salivary glands. History of any salivary gland surgery Follow a special diet in the last 3 months Pregnancy and lactation Patient dissatisfaction to participate in the study Taking dietary supplements in the last 3 months Suffering from certain diseases such as diseases caused by congenital diseases, immune system defects, etc. D44.0 Neoplasm of uncertain behavior of thyroid gland Treatment - Drugs Placebo Intervention group: Patients receiving a selenium capsule containing 200 micrograms of selenium per day for 10 days (3 days before treatment with radioactive iodine to 6 days after treatment with radioactive iodine) Control group: Patients receiving a placebo capsule containing 200 micrograms of maltodextrin per day for 10 days (3 days before radioactive iodine treatment to 6 days after radioactive iodine treatment) Clinical status of salivary glands. Timepoint: At baseline and end of the study. Method of measurement: Ultrasound of major salivary glands (including examination of echogenicity, size, margin and contour). C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test. Total oxidative stress. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Total antioxidant capacity. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit. Sense of taste. Timepoint: At baseline and end of the study. Method of measurement: Questionnaire designed by the researcher. The rate of salivary gland secretion. Timepoint: At baseline and end of the study. Method of measurement: Questionnaire designed by the researcher. Esfahan University of Medical Sciences Approved 2021-09-05 Ethics Committee of Isfahan University of Medical Sciences School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)