Comparison of the effects and adverse events of CinnaGen recombinant human growth hormone & Novo Nordisk growth hormone in children with growth hormone deficiency
- Conditions
- Idiopatic Growth Hormone Dificiency.Hypopituitarism
- Registration Number
- IRCT201409064920N5
- Lead Sponsor
- CinnaGen Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
age between 4 and 16 years, pre-pubertal or early puberty stage; height standard deviation score<-2 in diagnosis time; growth hormone level post stimulating test by clonidine <10 ng/ml; rule out of the other causes of growth hormone deficiency; Documented Pituitary or hypothalamic hormone deficiency or low normal serum IGF-1 at the time of diagnosis; In case of the deficiency in other pituitary hormones, the patient can only be included, if the replacement of other pituitary hormones was done
Exclusion criteria: acute or systemic disorders such as seizure, infectious diseases, chronic pulmonary infection, AIDS, chronic liver disease; Turner syndrome, chronic kidney disease; Any active malignancy; Contraindications of the administration of growth hormone (sleep apnea syndrome); Short stature due other causes of GHD; History of diabetes in patient or his/her first-degree relatives; prednisolone usage except for replacement therapy.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Growth velocity. Timepoint: befor intervention and at 3rd and 6th months of intervention. Method of measurement: assessment of height changes in time unit.
- Secondary Outcome Measures
Name Time Method Height Standard Deviation Score (HSDS). Timepoint: befor intevention and in 3rd and 6th month of intervention. Method of measurement: Growth Calculator 2.01.;Height Velocity Standard Deviation Score (HVSDS). Timepoint: At the end of 3rd and 6th month of intervention. Method of measurement: Growth Calculator 2.01.;The incidence of Adverse Events. Timepoint: befor intevention and in 3rd and 6th month of intervention. Method of measurement: Case report forms.;Weight. Timepoint: befor intevention and in 3rd and 6th month of intervention. Method of measurement: Scale.;Stutre status. Timepoint: befor intevention and in 3rd and 6th month of intervention. Method of measurement: Studiometer.