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IRCT20200731048259N1 IRCT 2021-12-20 Shahid Beheshti University of Medical Sciences Evaluation of the effect of levothyroxine in subclinical hypothyroidism Evaluation of the effects of levothyroxine treatment on fat profile and adult thyroid tests with subclinical hypothyroidism referred to Imam Hossein Hospital 2021-12-22 anticipated 60 Complete https://irct.ir/trial/50131 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Study as a three-blind clinical trial It is designed in such a way that from adults aged 18 to 50 years with sub clinical hypothyroidism and referring to the clinic, 60 patients who have just been diagnosed (have not been treated yet) are selected by the available method. Patients will be randomly assigned to the intervention and control groups based on the random number table. In using the random number table, the path will be from left to right. Even numbers will be assigned to the experimental group and individual numbers. Will be considered for assigning patients to the control group, Blinding description: Participants: With their consent, they choose one of the anonymous packages containing medicine or placebo. Principal Investigator: Throughout the project, it is not known which of the nodes of one or two patients in the placebo and which one received the drug. 3 Subclinical hypothyroidism. Intervention group: In the intervention group, levothyroxine (made by Iran Hormone Pharmaceutical Company) is used. This drug is in the form of 50 microgram tablets and is taken daily as a tablet for six months (in patients with coronary heart disease and underweight). 50 kg of half dose, ie 25 micrograms per day is used). Yes - There is a plan to make this available What will be shared: Data on the main outcome can be published When: Access starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: It can be used for scientific research and by submitting an application Where to obtain: Dr. Seyedeh Tahereh Mirsamadi Email address: doctor.mirsamadi@gmail.com How to obtain: The request should be sent to the mentioned email address and then the required data will be provided to the applicant Comments:
public Seyede Tahere Mirsamadi
Unit 6, Block 9, Narges 3,Imam Khomeini Town, Babaei Highway, Tehran
Tehran Iran (Islamic Republic of) 7654321879 +98 13 4275 3404 sarajm13@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyede Tahere Mirsamadi
Unit 6, Block 9, Narges 3,Imam Khomeini Town, Babaei Highway, Tehran
Tehran Iran (Islamic Republic of) 8765432109 +98 13 4275 3404 sarajm13@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People who have normal T4 and high TSH in their blood tests 18 years 50 years Both Taking anti thyroid drugs and lithium Treated with radiation therapy or thyroid surgery Iodine deficiency Pregnancy Central disorder (pituitary gland) E02 Sub clinical iodine-deficiency hypothyroidism Treatment - Drugs Intervention group: In the intervention group, levothyroxine (made by Iran Hormone Pharmaceutical Company) is used. This drug is in the form of 50 microgram tablets and is taken daily as a tablet for six months (in patients with coronary heart disease and underweight). 50 kg of half dose, ie 25 micrograms per day is used) Percentage of people whose lipid profile is affected by levothyroxine treatment. Timepoint: At the beginning of the study And 7 days later and 3 and 6 months after taking levothyroxine. Method of measurement: Laboratory data. Shahid Beheshti University of Medical Sciences Approved 2021-01-12 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences , Kodakiar Street , Shahid Shahriari Square, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)