Short stature due to endocrine disorder. Short stature due to endocrine disorder
Conditions
Interventions
Intervention 1: Intervention group: AryaTinaGen recombinant Growth Hormone, 35µg/kg/d, subcutaneous injection. Intervention 2: Control group: Norditropin recombinant Growth Hormone 35 µg/kg/d, subcuta
Sponsors
Arya Tina Gene company
Eligibility
Sex/Gender
All
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Children older than 2 and younger than 10 for girls and 11 for boys. Short stature with height standard deviation score (HSDS)?<?-3SD, No increase in growth hormone more than 10 or 20 mlU/L after fasting and clonidine stimulating test Signing the written informed consent by the gradians and assent by children older than 7
Exclusion criteria
Exclusion criteria: Any history of using GH or history of using estrogen of adrenal androgens within last year. History of seizure, sleep apnea syndrome or other respiratory disorders. Concomitant use of corticosteroid Any chronic systemic disorders such as hypothyroidism, DM, rickets, skeletal dysplasia, pervious chromosomal abnormalities Sensitivity to GH History of chemotherapy of radiotherapy Children with psychosocial dwarfism or idiopathic or familial short stature Children with idiopathic or familial short stature Spinal disorders such as scoliosis, kyphosis, chiari malformation, spinabifida variations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body height. Timepoint: Before treatment and 3, 6, 9 and 12 months later. Method of measurement: Using harpenden wall mounted stadiometer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin-Like Growth Factor 1 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.;Insulin-like growth factor-binding protein 3 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.;Bone age wrist. Timepoint: Before treatment and 12 months later. Method of measurement: Left wrist x-ray.;Weight. Timepoint: Before treatment and 3,6,9 and 12 months later. Method of measurement: Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAyat Ahmadi
Tehran University of Medical Sciences
Outcome results
None listed