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
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Primary outcomes
#1
The quality of life changes between baseline and follow-up visits of the Physical functioning domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Physical functioning domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#2
The quality of life changes between baseline and follow-up visits of the Social functioning domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Social functioning domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#3
The quality of life changes between baseline and follow-up visits of the Vitality domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Vitality domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه حیات در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه حیات در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#4
The quality of life changes between baseline and follow-up visits of the General mental health domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the General mental health domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه سلامت روان عمومی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه سلامت روان عمومی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#5
The quality of life changes between baseline and follow-up visits of the Bodily pain domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Bodily pain domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از دامنه درد بدن در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از دامنه درد بدن در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#6
The quality of life changes between baseline and follow-up visits of the Limitations in physical activities domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Limitations in physical activities domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت در فعالیت های بدنی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت در فعالیت های بدنی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#7
The quality of life changes between baseline and follow-up visits of the General health perceptions domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the General health perceptions domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه ادراکات سلامت عمومی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه ادراکات سلامت عمومی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#8
The quality of life changes between baseline and follow-up visits of the Limitations due to emotional problems domain in SF-36V1
empty
The quality of life changes between baseline and follow-up visits of the Limitations due to emotional problems domain in SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت ها به دلیل مشکلات عاطفی در SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت ها به دلیل مشکلات عاطفی در SF-36V1
Before study (baseline) , follow-up visit (6 months later)
empty
Before study (baseline) , follow-up visit (6 months later)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
Secondary outcomes
#1
empty
The quality of life changes between baseline and follow-up visits of the Physical functioning domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Physical functioning domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد فیزیکی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#2
empty
The quality of life changes between baseline and follow-up visits of the Social functioning domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Social functioning domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد اجتماعی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه عملکرد اجتماعی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#3
empty
The quality of life changes between baseline and follow-up visits of the Vitality domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Vitality domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه حیات در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه حیات در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#4
empty
The quality of life changes between baseline and follow-up visits of the General mental health domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the General mental health domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه سلامت روان عمومی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه سلامت روان عمومی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#5
empty
The quality of life changes between baseline and follow-up visits of the Bodily pain domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Bodily pain domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از دامنه درد بدن در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از دامنه درد بدن در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#6
empty
The quality of life changes between baseline and follow-up visits of the Limitations in physical activities domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Limitations in physical activities domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت در فعالیت های بدنی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت در فعالیت های بدنی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#7
empty
The quality of life changes between baseline and follow-up visits of the General health perceptions domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the General health perceptions domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه ادراکات سلامت عمومی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه ادراکات سلامت عمومی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
#8
empty
The quality of life changes between baseline and follow-up visits of the Limitations due to emotional problems domain in SF-36V1
The quality of life changes between baseline and follow-up visits of the Limitations due to emotional problems domain in SF-36V1
empty
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت ها به دلیل مشکلات عاطفی در SF-36V1
تغییرات کیفیت زندگی بین بازدیدهای اولیه و پیگیری از حوزه محدودیت ها به دلیل مشکلات عاطفی در SF-36V1
empty
Before study (baseline) , follow-up visit (6 months later)
Before study (baseline) , follow-up visit (6 months later)
empty
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
قبل از مطالعه (پایه)، ویزیت پیگیری (6 ماه بعد)
empty
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
The 36-item Short-Form Health Survey version 1 (SF-36V1) questionnaire
empty
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
پرسشنامه 36 سوالی فرم کوتاه بررسی سلامت نسخه 1 (SF-36V1)
Protocol summary
Study aim
the present RCT will be conducted to evaluate the effect of combined LT4+LT3 therapy vs LT4 alone on the quality of life.
Design
A randomized, double-blind, parallel-group comparison trial in a 1:1 ratio including the baseline (April- Oct 2020 ) and the 6-months follow-up
Settings and conduct
Hypothyroid patients with levothyroxine monotherapy and normal TSH
In this double blind study, patients divided in two groups
Place of study: Sayad Shirazi Hospital Endocrinology Clinic, Gorgan
Participants/Inclusion and exclusion 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 inclusion
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
Pregnancy or planned pregnancy within the next 6 months
Patients with drug or alcohol addiction
Patients with Malignancy, cardiovascular disease ,renal, or hepatic disease, chronic liver disease ,depression, anxiety
Patients with mental illness and had been on psychiatric medicine for 6 months before inclusion
Intervention groups
Patients will be randomized to continue receiving their usual dose of LT4 (100 µg/day) in the combination of placebo for 6 months (Group 1), or change their usual treatment to the combination therapy of LT4 50 µg and LT3 6.25 µg twice a day (Group 2)
The placebo will be “liothyronine” and labeled “approved for research purposes only”.
Main outcome variables
changes in quality of life between baseline and follow-up visits of the
General information
Reason for update
Change questionnaire
Acronym
IRCT registration information
IRCT registration number:IRCT20200410047012N1
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2022-08-07, 1401/05/16
Update count:4
Registration date
2020-06-12, 1399/03/23
Registrant information
Name
Fatemeh Hajtalebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 4068
Email address
fahajtalebi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
2020-03-19, 1398/12/29
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2021-03-18, 1399/12/28
Scientific title
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
Public title
effect of combination therapy of levothyroxine and levothyronine in comparison with levothyroxine in quality of life and cognitive function of patients with primary hypothyroidism
Purpose
Supportive
Inclusion/Exclusion 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:
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
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
158
Actual sample size reached:
151
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gorgan University of Medical Sciences
Street address
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
City
Gorgan
Province
Golestan
Postal code
4915663158
Approval date
2020-04-12, 1399/01/24
Ethics committee reference number
IR.Goums.Rec.1399.016
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
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
2
Description
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 outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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)
9
Description
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
10
Description
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
11
Description
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
12
Description
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
13
Description
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
14
Description
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
15
Description
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
16
Description
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
Intervention groups
1
Description
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)
Category
Treatment - Drugs
2
Description
the combination therapy of LT4 (LT4 dose at the time of inclusion-50 µg) and LT3 (6.25 µg twice a day) (Group 2).
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
City
Gorgan
Province
Golestan
Postal code
4915663158
Phone
+98 17 3245 1660
Email
fahajtalebi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data in this study can be shared without identifying individuals.
When the data will become available and for how long
Start access 3 months after printing the results
To whom data/document is available
Data from this study will only be available to researchers working at academic and research institutes and specialist physicians
Under which criteria data/document could be used
There are no restrictions on data analysis
From where data/document is obtainable
Dr. Fatemeh Talebi / Email: Fahajtalebi@yahoo.com/ Phone Number: 09151042897
What processes are involved for a request to access data/document
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).