Protocol summary

Summary
(1) Objectives: Our aim in this study was to investigate the effects of growth hormone on physical growth and clinical status of children with cystic fibrosis. (2) Design: This study is a before-after clinical trial which study population are 20 patients with cystic fibrosis diagnosed based on clinical evidence (steatorrhea, nasal polyp, rectum prolapse, history of ileus meconium and relapsing pneumonia), laboratory findings (sweat test more than 60 meq/dl) and genetic evaluation (mutation in CFTR gene) and referred to liver and gastrointestinal wards and clinics. These children will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent. (3) Setting and conduct: After measuring height, weight, body mass index and primary physical exam and filling checklists, blood sample will be taken to measure blood cells, blood glucose and electrolytes, creatinine, liver function tests and albumin. In first 6 months, without administrating growth hormone, growth rate, times of lung infections, times of intravenous antibiotic therapy and hospitalization will be measured every two months. After 6 months laboratory exams will be repeated and height and weight will be recorded and spirometry will be performed for all the patients. Growth hormone will be administered with dose of 35 mg/kg/week and will be injected subcutaneous every day. Growth rate and clinical status will be recorded every 2 months for six months. At the end of second six months laboratory exams and spirometry will be performed again. Inclusion criteria are age under 12 years old and height and weight less than third percentile for age and gender. Exclusion criteria are having diabetes, cirrhosis of the liver and hypoalbuminemia and oxygen-related lung disorders. (4) Interventions: Patients will be treated with growth hormone for six months with dose of 35 mg/kg/week and will be injected subcutaneous every day. (5) Main outcome measure: Height, weight, body mass index, times of hospitalizations, times of intravenous antibiotic therapy which will be recorded every two months after initiating treatment with growth hormone and will be continued for six months.

General information

Acronym
CF
IRCT registration information
IRCT registration number: IRCT201112275330N3
Registration date: 2013-06-28, 1392/04/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-28, 1392/04/07
Registrant information
Name
Mandana Rafeey
Name of organization / entity
Liver and gastrointestinal research center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 4135
Email address
rafieem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to investigate the effects of growth hormone on physical growth and clinical status of children with cystic fibrosis
Public title
Effects of growth hormone on status of children with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age under 12 years old; height and weight less than third percentile for age and gender; boyd mass index less than tenth percentile for age and gender. Exclusion criteria: Having diabetes (fasting glucose equal or less than 126 mg/dl); history of glucocorticoids in last 6 months; appearance of secondary sex characteristics; Cirrhosis of the liver and hypoalbuminemia; oxygen-related lung disorders.
Age
To 12 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Postal code
Approval date
2012-06-23, 1391/04/03
Ethics committee reference number
543081

Health conditions studied

1

Description of health condition studied
Cystic fibrosis with pulmonary manifestations
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations

Primary outcomes

1

Description
Weight
Timepoint
Before administering growth hormone and after administring growth hormone every 2 months for a period of 6 months
Method of measurement
Using scale

2

Description
Height
Timepoint
Before administering growth hormone and after administring growth hormone every 2 months for a period of 6 months
Method of measurement
Using meter

3

Description
Times of hospitalization
Timepoint
Before administering growth hormone and after administring growth hormone every 2 months for a period of 6 months
Method of measurement
Questionnaire

4

Description
Times of lung infection
Timepoint
Before administering growth hormone and after administring growth hormone every 2 months for a period of 6 months
Method of measurement
Questionnaire

5

Description
Times of intravenous antibiotic therapy
Timepoint
Before administering growth hormone and after administring growth hormone every 2 months for a period of 6 months
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
For all the patients, growth hormone will be injected subcutaneous with a dose of 35 mg/kg/week, daily and for six months
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Masoud Zamani
Street address
Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr. Masoud Zamani
Position
Pediatric diseases resident
Other areas of specialty/work
Street address
Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
5136735886
Phone
+98 41 1526 2255
Fax
Email
masoud.zamani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mandana Refeey
Position
Professor of pediatric gastroenterology
Other areas of specialty/work
Street address
Department of Pediatric diseases, Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1526 2255
Fax
Email
rafieem@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz Children Hospital
Full name of responsible person
Dr. Masoud Zamani
Position
Pediatric diseases resident
Other areas of specialty/work
Street address
Department of Pediatric diseases, Tabriz Children Hospital, Sheshgelan Street, Farmanfarmayan Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1526 2255
Fax
Email
masoud.zamani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...