Silver-Russell Syndrome (SRS)
Conditions
Interventions
Control Group:Placebo (Daytime/Nighttime), Powder for Oral Solution in Sachets. During the study period, one sachet of placebo (Daytime version) should be taken every morning and one sachet of placebo
Experimental group:iKids-Growth (day/night) , Powder for Oral Solution in Sachets. During the study period, one sachet of iKids-GrowthTM (Daytime version) should be taken every morning and one sachet
Sponsors
Children's Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1-3 years; 2. Diagnosed as SRS; 3. Height-for-age <= -2SD for the same gender and age group; 4. Height velocity <= 0.67SD (for the corresponding age); 5. The subject and/or legal representative understand the purpose of the study, the potential risks and benefits of the research, agree to participate in this clinical trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal blood glucose and blood lipids (fasting blood glucose >= 5.7 mmol/L, or cholesterol > 5.2 mmol/L, or triglycerides > 1.7 mmol/L); 2. Undergoing growth hormone treatment; 3. Liver and kidney dysfunction (ALT > 1.5 times the upper limit of normal, Cr > upper limit of normal); 4. Hypothyroidism (TSH >= 4.5 uIU/ml and low free T4 levels); 5. Other diseases or factors causing growth disorders (growth hormone deficiency, attachment deprivation, Turner syndrome, Laron syndrome, skeletal dysplasia, etc.); 6. Have received systemic or local treatment with other hormones (such as sex hormones, glucocorticoids, etc., for more than one month continuously) or medications that may interfere with GH secretion or GH action (e.g., oxandrolone, growth hormone releasing hormones) within 3 months; 7. Subjects who are allergic to the dietary supplements used in this clinical trial; 8. Subjects who have participated in a drug clinical trial within the past 3 months; 9. Subjects whose guardians is with cognitive impairments; 10. Other situations where the researcher considers the subject unsuitable for inclusion in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized height SDS increments; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1 and IGFBP-3;blood lipid ;blood glucose;thyroid function;sex hormone;liver and kidne function;bone age;body composition; | — |
Countries
China
Contacts
Public ContactQiang Shu, Jie Shao
Children's Hospital of Zhejiang University School of Medicine
Outcome results
None listed