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
1.Comparison of mean body weight in hypothyroid patients in the combination therapy and placebo group.
2. Comparison of mean physical_mental disorders score in hypothyroid patients in the combination therapy and placebo group.
3.Comparison of mean score of psychological field in hypothyroid patients in combination therapy and placebo group.
4.Comparison of mean social dysfunction score in hypothyroid patients in the combination therapy and placebo group.
5.Comparison of mean environmental mental disorder score in hypothyroid patients in the combination therapy and placebo group.
6. .comparison of mean physical activity score in hypothyroid patients in the combination therapy and placebo group.
Design
Randomized,double-blind,parallel-group study on 158 patients
Block randomization will be used.
Settings and conduct
Hypothyroid patients with levothyroxine monotherapy and normal TSH
In this double blind study, patients divided in two groups and received their regimens by health workers.
Place of study: Sayad Shirazi Hospital Endocrinology Clinic, Gorgan
Participants/Inclusion and exclusion criteria
1.Age > 16 years old
2.History of hypothyroidism more than 6 months
3.Regular use and fixed dose of the drug for 3 months
4.Symptoms of hypothyroidism with normal tests
5.The score above 23 according to the GHQ-28 General Health Standard Questionnaire
Intervention groups
Group A levothyroxine with placebo and group B levothyroxine and liothyronine 12.5 mcg twice daily
Main outcome variables
weight / lipid profile / quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200410047012N1
Registration date:2020-06-12, 1399/03/23
Registration timing:registered_while_recruiting
Last update:2020-06-12, 1399/03/23
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:
At least 6 months have passed since their hypothyroid diagnosis
Levothyroxine is taken regularly
Their dose of levothyroxine has been stable for the past 3 months
.Although their thyroid tests (TSH-T4) are in the normal range, they have symptoms such as fatigue, weight loss, lethargy, decreased psychomotor activity, and depression
Get a score above 23 based on the GHQ-28 General Health Standard Questionnaire
Exclusion criteria:
Malignancy
Pregnancy
Drug or alcohol addiction
Cardiovascular patients / Kidney failure / Liver failure / Patients with a history of heart disease/
Nervous disease or people who have been using psychiatric medication for the past 6 months
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:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Group A (levothyroxine and levothyronine recipients) and B (levothyroxine recipients alone) were divided. In this way, all possible four blocks (158 blocks), which include two groups, are written, and each number is assigned to one of the blocks in the table, which shows its own state. Randomly, based on the table of random numbers obtained by the computer program, a block is selected and based on that, the samples entered into the study will enter different groups. This work will continue to reach a sufficient number of samples in each group. For example, if block 1 is selected in the first selection, ie the first two samples enter group (A), the third and fourth samples enter group (B). And for the next 4 samples, the block will be selected again.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the drugs received in the two groups of patients are exactly the same shape and size and are given to them by clinical caregivers and patients are not aware of the type of drug combination. On the other hand, the researcher only examines and records the variables in the patients without knowing the type of medicine received.
Placebo
Not 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
Gorgan, Shast Kola Road, Golestan University of Medical Sciences
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
Quality of life score and cognitive function in the GHQ-28 General Health Standard Questionnaire
Timepoint
GHQ-28 standard health standard questionnaire score and IPAQ physical activity before intervention and 6 months after drug administration
Method of measurement
IPAQQ Physical Activity Questionnaire and GHQ-28 General Health
Secondary outcomes
1
Description
Quality of life score and cognitive function and feeling good
Timepoint
.Before the intervention and 6 months after taking the drug
Method of measurement
GHQ-28 Public Health Standard Questionnaire
Intervention groups
1
Description
Intervention group: Patients receiving levothyroxine and leiothyronine combination drugs/One group of levothyroxine with placebo and the other group of levothyroxine and leiothyronine in two doses of 6.25 per day
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).