Idiopatic Growth Hormone Dificiency. Hypopituitarism
Conditions
Interventions
Intervention 1: Intervention group: administration of 0.03 mg/kg/day of CinnaGen recombinant growth hormone, by subcutaneous injection for 3 months. Intervention 2: Control group: administration of 0.
Treatment - Drugs
Intervention group: administration of 0.03 mg/kg/day of CinnaGen recombinant growth hormone, by subcutaneous injection for 3 months
Control group: administration of 0.03 mg/kg/day of Novo Nordisk recombinant growth hormone, by subcutaneous injection for 3 months
Sponsors
CinnaGen Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
4 Years to 16 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth velocity. Timepoint: befor intervention and at 3rd and 6th months of intervention. Method of measurement: assessment of height changes in time unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Ramin Heshmat
Chronic Diseases Research Center
Outcome results
None listed