short children with low preadolescent IGF-1
Conditions
Interventions
iKids-Growth study group [iKids-Growth (Day/Night)]:None
Control group:None
Sponsors
Xiangya Hospital Zhuzhou Central South University
Eligibility
Sex/Gender
All
Age
5 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Age 5-10 years (i.e. 5 years and above, under 11 years, excluding 11 years); 2. Prepubescent (male children: Tanner external genital stage 1; Female children: Tanner breast stage 1); 3. The standard deviation score of height corresponding to the same sex and age is -2SDS; 4. The standard deviation of IGF-1 level in serum of the same sex and age is -2SDS; 5. The difference between bone age and actual age was 24 months or less; 6. Non-organic short height children; Seven. Participants will take the children's dietary supplement Akifu iKids-Growth, or not; 8. Participants and/or guardians understand the purpose of the study, the possible risks and benefits of the study, agree to participate in the clinical study, and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal blood glucose (fasting blood glucose >= 5.6mmol/L); 2. Two or more stages of Tanner external genital development in male children and two or more stages of Tanner breast development in female children; 3. Liver and kidney dysfunction (ALT > 1.5 times the upper limit of normal, Cr > the upper limit of normal); 4. Have been diagnosed with other genetic metabolic disorders affecting growth and height development: Such as intrauterine growth retardation (IUGR), small for gestational age (SGA), idiopathic short stature (ISS), growth hormone deficiency (GHD), Turner syndrome, Parder-Willi syndrome (PWS), Noonan syndrome, Laron syndrome, etc. 5. Is receiving or has previously received growth hormone treatment; 6.3 Have received any medication (including but not limited to oxandrolone, Danazole, stanazol, etc.) that may interfere with growth hormone secretion or growth hormone action within the last month; 7. Standard deviation score of corresponding age and height <= -2SDS; 8. History of severe congenital heart disease, asthma, chronic liver disease, kidney disease and other systemic diseases; 9. Participants who are allergic to the dietary supplements used in this clinical study; 10.3 Participated in drug clinical investigators within the past months; 11. The guardian has cognitive impairment; 12. Other conditions deemed unsuitable for inclusion in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual height standard deviation score change (?HtSDS); | — |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1;Predicted Final Height Change;Annual height velocity;Metabolic indicators change;Bone age maturity (bone age/calendar age);Liver and kidney function indicators change;Tanner Stage;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactXianglan Wen
Xiangya Hospital Zhuzhou Central South University
Outcome results
None listed