Children in puberty with stature in the low-normal range
Conditions
Interventions
Blank control group:None
iKids-Growth study group:None
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
10 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1 Girls aged 10-14 years (i.e., 10 years and above, 13 years and 12 months and below) and boys aged 11-15 years (i.e., 11 years and above, 14 years and 12 months and below); 2 Puberty development (tanner Stage =II for genital/breast development); 3 Compared with people of the same gender and age, the current height percentile is > P3 and < P25; 4 *Predict lifetime height < genetic target height; 5 Girls' bone age < 14 years old, boys < 15 years old; 6 **Will take iKids-Growth or not during the study; 7 Participants and/or their legal guardians, having understood the study objectives, potential risks, and benefits, voluntarily agreed to participate in this clinical research and provided written informed consent.
Exclusion criteria
Exclusion criteria: 1 Previously diagnosed with growth disorders caused by other diseases or factors (history of growth hormone deficiency, precocious puberty, delayed puberty development, attachment deprivation, Turner syndrome, Laron syndrome, achondroplasia and other growth disorders); 2 The difference between bone age and chronological age is more than ± 24 months; 3 Participants with abnormal blood glucose (fasting blood glucose = 5.6mmol/L); 4 Those with abnormal liver and kidney function (ALT> upper limit of normal value 1.5 times, Cr > upper limit of normal value); 5 Those with abnormal thyroid function (TSH=4.5uIU/ml, and low free T4 level); 6 Those who are receiving growth hormone therapy, or those who have received growth hormone therapy in the past and have stopped the drug for less than 6 months; 7 Received drug treatment within 3 months that may interfere with growth hormone secretion, growth hormone action, or interfere with the normal physiological state of the gonadal axis: including but not limited to oxandrolone, danazol, stanzolol, etc., 8 excluding gonadotropin-releasing hormone analogues (GnRHa) and aromatase inhibitors; 9 Systemic glucocorticoid therapy (topical or inhaled glucocorticoids are allowed) for more than 1 month; 10 Have severe congenital heart disease, history of asthma, chronic liver disease, kidney disease and other systemic diseases; 11 Participants who are allergic to the dietary supplements used in this clinical study or have a known high allergic constitution; 12 Are participating in other clinical investigators, or have participated in other clinical investigators within 3 months of enrollment; 13 The guardian has cognitive impairment; 14 Other situations that the investigator believes are not suitable for inclusion in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of height standard deviation score(?HtSDS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum IGF-1 levels;change in annualized height velocity;Metabolic indicators;Liver and kidney function indicators;Sex hormone levels;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactWenjin Xiao
The Second Affiliated Hospital of Soochow University
Outcome results
None listed