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Evaluation of estrogen therapy on final height of short girls with chronic kidney disease (CKD) and delayed puberty

Protocol summary

Study aim
Determining the effect of estrogen therapy on the final height of short girls with chronic kidney disease (CKD) and delayed puberty
Design
A clinical trial with control group, with parallel groups, without blinding, without randomization, phase 3 on 75 patients.
Settings and conduct
This study is conducted on 75 children with CKD referred to Aliasghar children’s Hospital. Children are divided into 3 groups. In the first intervention group, growth hormone and estrogen are prescribed from the age of 11 years. In the second intervention group, hormones and estrogen are prescribed from the age of 13 years. In the control group, patients do not receive growth hormone and estrogen until the age of 15, blinding is not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: consent to participate in the study, patients with chronic kidney disease (CKD), girls with short stature, beginning of dialysis around 3.5 to 5 years. Exclusion criteria: Incidence of puberty before the estrogen therapy, kidney transplantation before the study.
Intervention groups
In the first intervention group, patients receive injection of growth hormone (Genotropin manufactured by Pfizer, US), at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 11at the rate of 5 µg once a day until the age of 16. In the second intervention group, patients receive injection of growth hormone (Genotropin manufactured by Pfizer, US), at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 13 at the rate of 5 µg once a day until the age of 16. In the control group, patients do not receive growth hormone and estrogen until the age of 15
Main outcome variables
Final height after 15 years old

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201110049334N1
Registration date: 2021-01-30, 1399/11/11
Registration timing: registered_while_recruiting

Last update: 2021-01-30, 1399/11/11
Update count: 0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
Davood Amirkashani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
amirkashani.d@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of estrogen therapy on final height of short girls with chronic kidney disease (CKD) and delayed puberty
Public title
Evaluation of estrogen therapy on the height of children with chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient and parent consent to participate in the study. Patients with chronic kidney disease (CKD). Patients must be girls. With short stature (height and growth velocity respectively below 3th and 25th percentile for more than 1 year). In all patients, beginning of dialysis around 3.5 to 5 years. Growth hormone has been started in all patients from the age of 5.5 to 8 years, despite therapeutic indications.
Exclusion criteria:
Incidence puberty before the estrogen therapy Kidney transplantation before the study
Age
From 3 years old to 7 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to the Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1453514496
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.IUMS.REC.1399.708

Health conditions studied

1

Description of health condition studied
Short stature
ICD-10 code
N25
ICD-10 code description
Disorders resulting from impaired renal tubular function

Primary outcomes

1

Description
Final height after 15 years old
Timepoint
Before the intervention and after the age of 15
Method of measurement
Height gauge

Secondary outcomes

1

Description
Bone density
Timepoint
Before the intervention and after the age of 15
Method of measurement
Dexa bone densitometry

Intervention groups

1

Description
ّFirst intervention group: In this group, patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature, at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 11at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16.
Category
Treatment - Drugs

2

Description
Second intervention group: In this group, patients (N = 25) receive injection of growth hormone (Genotropin manufactured by Pfizer, US) from the beginning of short stature, at the rate of 0.05 mg/kg, once a day for 4-6 years and oral Estrogen (Ethinyl Estradiol, manufactured by Aburaihan, Iran) from the age of 13 at the rate of 5 µg ( it will double every 3 to 6 months until to reach a dose of 30 µg) once a day and continues until the age of 16.
Category
Treatment - Drugs

3

Description
Control group: in this group patients (N = 25) do not receive growth hormone and estrogen until the age of 15 and are the same with both intervention groups in terms of age, sex, average parental height and stage of chronic kidney disease (There is no intervention in this group).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliasghar Children's Hospital
Full name of responsible person
Davod Amirkashani
Street address
No193, zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Next to the Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1453514496
Phone
+98 21 8670 2503
Email
motevalian.a@iums.ac.ir
Grant name
Aliasghar Clinical Research Development Center
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway.
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Davod Amirkashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No193, zafar St, Modares Highway.
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
amirkashani.d@iums.ac.ir

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
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