Slow preadolescent growth
Conditions
Interventions
iKids-Growth treatment group [iKids-Growth (Day/Night)]:None
Control group (No treatment):None
Sponsors
Children's Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 7 Years
Inclusion criteria
Inclusion criteria: (1) Age 5-7 years old; (2) in the pre-pubertal stage (male children: Tanner external genital development stage 1; Female children: Tanner breast stage 1); (3) The height percentile of the same age and sex is > P3 and =P10; (4) * Predicted final height < genetic target height; (5) The growth rate of height in the previous year was lower than the average growth rate of height in the same age and gender; (6) ** Subjects only take the children's dietary supplement iKids-Growth for height improvement during the study period, or did not receive any treatment; (7) Do not take other hormone therapy (such as growth hormone, sex hormone, glucocorticoid, etc.) and accept drug therapy that interferes with growth hormone secretion or growth hormone effect (such as Oxandrolone, growth hormone releasing hormone, etc.) treatment; (8) Subject and/or guardian understand the purpose of the study, the possible risks and benefits of the study, agree to participate in the clinical study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with abnormal blood glucose (fasting blood glucose =5.7mmol/L); (2) Adolescent sexual development occurs; (3) Liver and kidney dysfunction (ALT> 1.5 times the upper limit of normal, Cr> the upper limit of normal); (4) Thyroid related diseases; (5) Diagnosed with growth hormone deficiency (GHD), idiopathic short stature (ISS), Turner syndrome, Parder-Willi syndrome (Prader-Willi syndrome), Noonan syndrome (Noonan syndrome); (6) have been diagnosed with other growth and development-related diseases; (7) Patients who have used systemic or local hormone therapy (such as growth hormone, sex hormone, glucocorticoid, etc.) within 3 months and have received drug therapy that may interfere with GH secretion or GH effect (oxandrosterone, growth hormone-releasing hormone, etc.); (8) Corresponding age and height percentile =P3; (9) Have a history of severe congenital heart disease, asthma, chronic liver disease, kidney disease and other systemic diseases; (10) Subjects who are allergic to the dietary supplements used in this clinical study; (11) * Participated in drug clinical investigators within 3 months; (12) The guardian has cognitive impairment; (13) Other conditions deemed unsuitable for inclusion in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height standard deviation Score Change (?HtSDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1;IGFBP-3;Predicted Final Height Change;annual height velocity;annual height velocity change;Bone age maturity (bone age/calendar age);Metabolic indicators (fasting blood glucose);Liver and kidney function (total bilirubin, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, serum creatinine, serum urea);Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactWei Gu
Children's Hospital of Nanjing Medical University
Outcome results
None listed