idiopathic short stature
Conditions
Interventions
Growth hormone group:None
Blank control group:None
iKids-Growth:None
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
4 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1.ISS was diagnosed clinically in our center. Aged 4-10 years (i.e. 4 years and above, 10 years and 11 months and below); 2.Prepubertal (Tanner stage 1 breast development in females and testicular volume < 4ml in males); 3.Compared with people of the same race, sex, and age, height standard deviation score < -2SDS or height percentile < P3; 4.No treatment, akifu alone, or short-acting rhGH alone during the study; 5.Participants and/or guardians were aware of the purpose of the study, possible risks and benefits of the study, agreed to participate in this clinical study, and voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Height disorders caused by other causes were diagnosed, including but not limited to growth hormone deficiency (GHD), SHOX deficiency, Turner syndrome, Parder-Willi syndrome (PWS), Noonan syndrome, congenital hypothyroidism (CH), etc. A diagnosis of moderate to severe scoliosis; 2.Have entered puberty (sex hormone levels at adolescent levels); 3.Patients with blood glucose and dyslipidemia (fasting blood glucose >=5.6mmol/L, or cholesterol >=5.18mmol/l and triglyceride >=1.7mmol/l); 4.Hepatic and renal insufficiency (ALT> 1.5 times upper limit of normal, Cr > upper limit of normal); 5.Thyroid insufficiency (TSH>=4.5uIU/ml and low free T4 level); 6.A history of severe congenital heart disease, asthma, or other systemic diseases such as chronic liver disease or kidney disease; 7.Prior treatment with growth hormone; 8.Medications that may interfere with the secretion or action of growth hormone (including but not limited to oxandrosterone, danazol, stanazolol, etc.) have been received within 3 months; 9.Systemic glucocorticoid therapy (topical or inhaled glucocorticoids were allowed) for more than 1 month; 10.Severe congenital heart disease, asthma, chronic liver disease, kidney disease and other systemic diseases; 11.Participants who were allergic to the dietary supplements used in the study or who were known to be highly allergic; 12.Are currently enrolled in another clinical investigator or have been enrolled in another clinical investigator within 3 months before enrollment; 13.The guardian has cognitive impairment; 14.Other conditions that were considered by the investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annual growth rate was improved;Height-standard deviation scores improved;IGF-1?IGFBP-3; | — |
Countries
China
Contacts
Public ContactHaiying Chen
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed