SHOX Deficiency (SHOX-D)
Conditions
Interventions
SHOX-D control group:Short-acting recombinant human growth hormone injection + Placebo (Day/Night)
SHOX-D combined treatment group:Short-acting recombinant human growth hormone injection +iKids-Growth (Day/Night)
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 11 Years
Inclusion criteria
Inclusion criteria: (1) Aged 5-11, i.e. 5 years old and above, under 12 years old, excluding 12 years old; (2) prepubertal (Male: Tanner external genital development stage 1; Female: Tanner breast stage 1); (3) SHOX-D was genetically diagnosed; (4) Height corresponding to the same sex age =-2SD; (5) The subject and/or guardian understand the purpose, possible risks, and benefits of the study, then agree to participate in the clinical study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with dysglycemia (fasting blood glucose =5.7 mmol/L, or cholesterol >5.2 mmol/L, or triglyceride >1.7 mmol/L); (2) Serum gonadotropin and sex hormone reached pubertal levels; (3) being treated with growth hormone; (4) Hepatic and renal dysfunction (ALT> 1.5 times the upper limit of normal, Cr > the upper limit of normal); (5) Thyroid insufficiency (TSH=4.5 uIU/mL, low level of free T4); (6) Growth disorders caused by other diseases or factors (growth hormone deficiency, attachment deprivation, etc.); (7) Systemic or local use or injection of other hormone therapy within 3 months (such as sex hormones, glucocorticoids, etc. : continuous use of more than one month) and received drug treatment that may interfere with GH secretion or GH effect (oxandrosterone, growth hormone releasing hormone, etc.); (8) Subjects who are allergic to the dietary supplements used in this clinical study; (9) Participated in drug clinical investigators within 3 months; (10) The guardian has cognitive impairment; (11) Other conditions deemed unsuitable for inclusion in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| annual height velocity;treatment effect and difference between control group and combined treatment group; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1 ;IGFBP-3;blood lipids;glucose;glycosylated hemoglobin;insulin;HOMA-IR;the maturity of bone age; | — |
Countries
China
Contacts
Public ContactMin Zhu
Children's Hospital of Chongqing Medical University
Outcome results
None listed