Hypothyroidism. Other hypothyroidism
Conditions
Interventions
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
Sponsors
Gorgan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 stud | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Hamide Akbari
Gorgan University of Medical Sciences
Outcome results
None listed