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IRCT20200502047270N1 IRCT 2020-07-04 Zahedan University of Medical Sciences Evaluation of selenium effect on thyroid function Investigation of the effect of selenium on thyroid function test in hemodialysis patients 2020-05-21 anticipated 34 Complete https://irct.ir/trial/47673 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Investigation of the effect of selenium on thyroid function in hemodialysis patients, Randomization description: Simple randomization All eligible hemodialysis patients, if desired, entered the study through a table of random numbers and were placed in two groups of case and control, Blinding description: The researcher personally puts the drug or placebo in the package and set the patients in the case or control group according to the table of random numbers and numbers the package related to each patient and the others are blind to the type of packaged content. Other people, such as the clinical caregiver and drug distributor and data analyzer, know the groups only on the A and B levels and are blind to the case or control of the groups. 3 End Stage Renal Disease. Intervention 1: Intervention group: Selenium 200 mg receiving group as oral capsule from 20th Century Pharmaceutical Company for 3 months daily capsule version. Intervention 2: Control group: The control group receives the placebo as an oral capsule of exactly the same shape and color of the main drug made by the pharmacy of the research center of the relevant university containing starch for 3 months daily.main drug. Yes - There is a plan to make this available What will be shared: Data on the main implications of the study will be made available to scientific and service organizations and institutions in a report six months after the end of the intervention. When: six months after the end of the intervention To whom: All applicants Conditions: The data are available for scientific and academic reasoning and for researchers to investigate similar interventions. The only condition for access is the confidentiality of patient information. Where to obtain: Dr. Zahra Adineh By email drzahraadineh@gmail.com How to obtain: Request via email and state the reason for the request. Comments:
public Zahra Adineh
Ali Ibn Abitaleb hospital, Khalige fars Blvd
Zahedan Iran (Islamic Republic of) 9817958569 +98 54 3328 5279 drzahraadineh@gmail.com Zahedan University of Medical Sciences scientific Zahra Adineh
Ali Ibn Abitaleb hospital, Kalige Fars Blvd
Zahedan Iran (Islamic Republic of) 9817958569 +98 54 3328 5279 drzahraadineh@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Hemodialysis duration more than 6 months 18 years 80 years Both Sensitivity to selenium Selenium consumption over the past 3 months Thyroid disease needs treatment N18.6 End stage renal disease Treatment - Drugs Placebo Intervention group: Selenium 200 mg receiving group as oral capsule from 20th Century Pharmaceutical Company for 3 months daily capsule version Control group: The control group receives the placebo as an oral capsule of exactly the same shape and color of the main drug made by the pharmacy of the research center of the relevant university containing starch for 3 months daily.main drug Changes in serum free T4. Timepoint: At the beginning of the intervention and 12 weeks after the start of the intervention. Method of measurement: Chemi Luminescence. Changes in serum free T4. Timepoint: At the beginning of the intervention and 12 weeks after the start of the intervention. Method of measurement: Chemi Luminescence. Changes in TSH level. Timepoint: At the beginning of the intervention and 12 weeks after the start of the intervention. Method of measurement: Chemi Luminescence. Changes in rT3 level. Timepoint: At the beginning of the intervention and 12 weeks after the start of the intervention. Method of measurement: Chemi Luminescence. Changes in Selenium level. Timepoint: At the beginning of the intervention and 12 weeks after the start of the intervention. Method of measurement: atomic absorption spectrophotometry. Zahedan University of Medical Sciences Approved 2019-12-14 Ethics Committee of Zahedan University of Medical Sciences Ali Ibn Abotaleb ,Khalije fars Boulv. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)