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IRCT20200410047012N1 IRCT 2020-06-12 Gorgan University of Medical Sciences effect of combination therapy of levothyroxine and levothyronine in comparison with levothyroxine in quality of life and cognitive function of patients with primary hypothyroidism Study the effect of combination therapy with levothyroxine and leiothyronine in comparison with levothyroxine on Well-Being, Quality of Life, or Cognitive Function in Patients with Primary Hypothyroidism 2020-03-19 anticipated 158 Complete https://irct.ir/trial/47402 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: We will design a randomized, double-blind (both patients and physicians), parallel-group comparison trial in a 1:1 ratio, and patients are randomly assign following procedures to LT4+placebo or LT4+LT3 treatment groups. The list of random allocation cards will be generated by an independent trained researcher using computer-generated random numbers. To avoid the confusion of coding A or B, the researcher will keeps the original random allocation sequences in an inaccessible third place and works with a copy, Blinding description: The placebo will be placed into envelopes according to the allocation orders by another independent nurse who was not aware of the study. The patient's ID, visit date, and other information will be recorded on each envelope. Neither the patients nor the physicians who will assess the patients are aware of the treatment. After 6 months, another independent researcher who is not aware of the treatment will assess the patient's health-related quality of life scores. 3 Hypothyroidism. Intervention 1: Patients are randomized to continue receiving their usual dose of LT4 (starting dose of an average of 100 µg/day) in the combination of placebo (liothyronine: to ensure blinding) for 6 months (Group 1). Intervention 2: the combination therapy of LT4 (LT4 dose at the time of inclusion-50 µg) and LT3 (6.25 µg twice a day) (Group 2). Yes - There is a plan to make this available What will be shared: All data in this study can be shared without identifying individuals. When: Start access 3 months after printing the results To whom: Data from this study will only be available to researchers working at academic and research institutes and specialist physicians Conditions: There are no restrictions on data analysis Where to obtain: Dr. Fatemeh Talebi / Email: Fahajtalebi@yahoo.com/ Phone Number: 09151042897 How to obtain: The applicant will be able to access the document after submitting documents regarding the reason for requesting the data file and determining the identity of the person (specialist or researcher). Comments:
public Dr Hamide Akbari
Endocrinology and Metabolism Clinic, Ground Floor, Shahid Sayad Shirazi Hospital, Sayad Shirazi Blvd., Bahonar Square, Gorgan, Iran
Gorgan Iran (Islamic Republic of) 4915663158 +98 17 3220 3564 fahajtalebi@yahoo.com Gorgan University of Medical Sciences scientific Fatemeh Hajtalebi
Alley of Martyr Shibak_Janbazan Boulevard
Gorgan Iran (Islamic Republic of) 4915663158 +98 17 3235 4068 fahajtalebi@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Age over 16 years Being able to read and understand Persian Diagnosis of overt hypothyroidism at least 6 months before inclusion Stable and regular LT4 monotherapy for at least 3 months before Patient-reported signs and symptoms of hypothyroidism including fatigue, mood change, weight gain, lethargy, decreased psychomotor performance conative, depression, and disturbances despite normal thyroid hormone levels 16 years no limit Both Pregnancy or planned pregnancy within the next 6 months Patients with drug or alcohol addiction Patients with Malignancy Patients with cardiovascular disease Patients with renal, or hepatic disease Patients with chronic liver disease Patients with depression, anxiety Patients with mental illness and had been on psychiatric medicine for 6 months before inclusion E03 Other hypothyroidism Treatment - Drugs Treatment - Drugs Patients are randomized to continue receiving their usual dose of LT4 (starting dose of an average of 100 µg/day) in the combination of placebo (liothyronine: to ensure blinding) for 6 months (Group 1) the combination therapy of LT4 (LT4 dose at the time of inclusion-50 µg) and LT3 (6.25 µg twice a day) (Group 2). The quality of life changes between baseline and follow-up visits of the Physical component summary in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Mental component summary in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. Changes between baseline and follow-up visits of the weight. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: digital scale. Changes between baseline and follow-up visits of the Blood pressure. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: manual auscultatory device. Changes between baseline and follow-up visits of the Serum TSH. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: immunochemiluminometric assay. Changes between baseline and follow-up visits of the Serum total cholesterol. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: enzymatic colorimetric methods. Changes between baseline and follow-up visits of the Serum triglyceride. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: enzymatic colorimetric methods. Changes between baseline and follow-up visits of the Serum LDL cholesterol. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: enzymatic colorimetric methods. Changes between baseline and follow-up visits of the Serum HDL cholesterol. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: precipitation method. Changes between baseline and follow-up visits of the in physical activity. Timepoint: Before the intervention and 6 months after taking the drug. Method of measurement: International Physical Activity Questionnaire short form (IPAQ20). The quality of life changes between baseline and follow-up visits of the Physical functioning domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Social functioning domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Vitality domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the General mental health domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Bodily pain domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Limitations in physical activities domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the General health perceptions domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. The quality of life changes between baseline and follow-up visits of the Limitations due to emotional problems domain in SF-36V1. Timepoint: Before study (baseline) , follow-up visit (6 months later). Method of measurement: The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire. Gorgan University of Medical Sciences Approved 2020-04-12 Ethics committee of Gorgan University of Medical Sciences Ethics Committee of the Vice Chancellor for Research and Technology, 3rd Floor, School of Dentistry, Golestan University of Medical Sciences, Shast Kola Road, Gorgan, Iran Gorgan Golestan Iran (Islamic Republic of)