The Effect of Levothyroxine on Cardiac Function in Children with Subclinical Hypothyroidism
Design
Clinical trial without control group; the sample size includes all of the eligibility criteria that 30-sample are predictable, phase 2 clinical trial.
Settings and conduct
This clinical trial study was performed will be selected by an inhomogeneous method in Children aged 4-12 years with subclinical hypothyroidism referring to Amirkola Children's Hospital Endocrinology Clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 4-12 years with subclinical, Exclusion Criteria: Obese children, Children with high blood pressure, Children who already use levothyroxine, Children with congenital or acquired heart disease proven and under medical treatment, Children with liver or kidney disease, Children with high blood lipids, Children with diabetes, Children with infectious diseases.
Intervention groups
Children aged 4 to 12 years who referred to the endocrinology clinic were diagnosed with subclinical hypothyroidism. Treatment with 0.1 mg levothyroxine tablets starts with hormones with a dose of 4 micrograms per kilogram per day, which will be used by the patients in the early hours of fasting.
Main outcome variables
LVSD ، LVDD ، FS ، EF ، E/E' ،MPI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180228038900N3
Registration date:2018-12-02, 1397/09/11
Registration timing:registered_while_recruiting
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Morteza Alihanpour Aghamaleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3234 6963
Email address
m.alijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-14, 1397/07/22
Expected recruitment end date
2019-10-14, 1398/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Levothyroxine on Cardiac Function in Children with Subclinical Hypothyroidism
Public title
The Effect of Levothyroxine on Cardiac Function in Children with Subclinical Hypothyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of subclinical hypothyroidism
Exclusion criteria:
Obese children
Children with hypertension
Children who already use levothyroxine
Children with congenital or acquired heart disease proven and under medical treatment
Children with liver or kidney disease
Children with high blood lipids
Children with diabetes
Children with infectious diseases
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Vice- Chancellor for Research Technology Affairs, Babol University of Medical Sciences, Ganjafroz Street