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IRCT20210331050794N1 IRCT 2021-05-15 Kermanshah University of Medical Sciences Effect of sodium levothyroxine on Electrocardiographic findings (QTc and QTd) Effect of sodium levothyroxine on Electrocardiography findings(QTc & QTd) of subclinical hypothyroidism patients 2021-05-22 anticipated 200 Complete https://irct.ir/trial/55268 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: After obtaining informed consent using block randomization and allocation ratio 1: 1, participants will be randomly divided into two study groups. A combination of 4 and 6 random blocks generated by the sealed envelope website, https://www.sealedenvelope.com, will be used to assign intervention to participants. On this website, after setting the seed, we will generate a list of 200 numbers to assign participants into two groups, A and B. Then, using the mentioned list, patients were divided into designated groups. Once participants have consented, each participant will be given a study identification number at the study site. In order to conceal the randomization process, the allocation sequence is given to the person in charge of randomization in the clinic in a sealed form using envelopes containing the number of numbers, Blinding description: The study will be designed to be double-blind, the participants in the study and the physician responsible for electrocardiography will not be aware of the assigned treatments. The levothyroxine sodium (50 M) produced by Iran Hormone Pharmaceutical Company will be used in the study. The placebo is also produced by the same company and will be similar in terms of shape, packaging, color size and smell. 3 Subclinical hypothyroidism. Intervention 1: Intervention group: will receive 50 micrograms of levothyroxine sodium daily for 3 months . Intervention 2: Control group: Includes patients with subclinical hypothyroidism with a TSH of 5-10 ng / dL who will receive a placebo daily for 3 months. The duration, method of use and follow-up of control group will be completely similar to the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Asadollah Amiripour
Imam Ali Cardiovascular Hospital, Kermanshah University of Medical Sciences, Shahid Beheshti Street
Kermanshah Iran (Islamic Republic of) 6714673159 +98 83 3838 6835 asadamiri1351@yahoo.com Kermanshah University of Medical Sciences scientific Asadollah Amiripour
Imam Ali Cardiovascular Hospital, Kermanshah University of Medical Sciences, Shahid Beheshti Street
Kermanshah Iran (Islamic Republic of) 6714673159 +98 83 3837 0252 asadamiri1351@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) TSH levels greater than 5 nanograms per deciliter and normal thyroid hormones QTc greater than 460 ms absence of heart disease Age range 20-50 years 20 years 50 years Both Pregnancy or hormonal disorder Taking drugs that affect the QTc interval E02 Subclinical iodine-deficiency hypothyroidism Prevention Placebo Intervention group: will receive 50 micrograms of levothyroxine sodium daily for 3 months . Control group: Includes patients with subclinical hypothyroidism with a TSH of 5-10 ng / dL who will receive a placebo daily for 3 months. The duration, method of use and follow-up of control group will be completely similar to the intervention group. Change in QTc&QTd interval. Timepoint: QTc & QTd measurements will be performed before the intervention and 3 months after receiving the intervention. Method of measurement: QTc & QTd measurements will be performed using electrocardiography. Kermanshah University of Medical Sciences Approved 2021-01-12 Kermanshah University of Medical Sciences Imam Ali Cardiovascular Hospital, Kermanshah University of Medical Sciences, Shahid Beheshti Street Kermanshah Kermanshah Iran (Islamic Republic of)