Evaluation of Changes in Electrocardiogram's Intervals During Treatment with Gonadotropin-Releasing Hormone Agonists in Patients with precocious puberty
Evaluation of Changes in Electrocardiogram's Intervals During Treatment with Gonadotropin-Releasing Hormone Agonists in Patients with precocious puberty
Design
A before-after clinical trial on 50 children with precocious puberty without any control group.
Settings and conduct
The electrocardiograms of studied patients were evaluated and compared them before starting treatment with gonadotropin releasing hormones agonists and at 3, 6, 12, and 18 weeks after the treatment in Tabriz Children's Hospital.
Participants/Inclusion and exclusion criteria
Children with precocious puberty referring to the Endocrinology Clinic of Tabriz Children Hospital who had the indication to treat with gonadotropin releasing hormone agonists are included in this study. Patients will not be included in the study if there is any previous cardiovascular disease.
Intervention groups
Children with precocious puberty that Triptorelin will be administered as gonadotrophin hormone agonist.
Main outcome variables
Electrocardiogram
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190314043051N1
Registration date:2019-03-18, 1397/12/27
Registration timing:prospective
Last update:2019-03-18, 1397/12/27
Update count:0
Registration date
2019-03-18, 1397/12/27
Registrant information
Name
Ali Bagherzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3380 1458
Email address
bagherzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Changes in Electrocardiogram's Intervals During Treatment with Gonadotropin-Releasing Hormone Agonists in Patients with precocious puberty
Public title
The Effect of Triptorelin on Electrocardiogram
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children with precocious puberty
Referring to Endocrinology Clinic of Tabriz Children Hospital
Exclusion criteria:
Having any type of previous cardiac disease
Age
From 2 years old to 9 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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 Tabriz University of Medical Sciences
Street address
3rd Floor, No. 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665935
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1072
Health conditions studied
1
Description of health condition studied
precocious puberty
ICD-10 code
E30.1
ICD-10 code description
Precocious puberty
Primary outcomes
1
Description
QRS interval duration in electrocardiogram
Timepoint
Before the intervention and 6, 12, and 18 weeks after the starting of gonadotropin releasing hormone agonists
Method of measurement
Electrocardiography
2
Description
PR interval duration in electrocardiogram
Timepoint
Before the intervention and 6, 12, and 18 weeks after the starting of gonadotropin releasing hormone agonists
Method of measurement
Electrocardiography
3
Description
QT interval duration in electrocardiogram
Timepoint
Before the intervention and 6, 12, and 18 weeks after the starting of gonadotropin releasing hormone agonists
Method of measurement
Electrocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Triptorelin (FERRING, Germany) as a gonadotropin-releasing hormone agonist in the form of 0.1 mg ampule will be administered as the intramuscular injection once a month to children with precocious puberty at a dose of 75 μg/kg body weight for at least 18 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Siamak Shiva
Street address
Sheshgelan street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Fax
+98 41 3526 2265
Email
kodakanhospital@tbzmed.ac.ir
Web page address
https://childrenhospital.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
3rd Floor, No. 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665935
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Siamak Shiva
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665935
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
shivasiamak@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Siamak Shiva
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
shivasiamak@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Bagherzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2251
Email
dralib@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available