Effects of recombinant human growth hormone on autistic behavior and cognitive development in children with short stature comorbidity with autism spectrum disorder: an exploratory study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100049963

Enrollment

Unknown

Registered

2021-08-15

Start date

2021-11-02

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Stature comorbidity with Autism spectrum disorder

Interventions

rhGH use group:rhGH and Routine behavior intervention

rhGH unused group:Routine behavior intervention

Eligibility

Sex/Gender

All

Age

3 Years to 9 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3 to 9 years; 2. The height of the child is 2 standard deviations (-2 SD) lower than the average height of the normal population of the same race, gender and age in a similar living environment, or lower than the 3rd percentile (-1.88 SD); And meet any one of the following types of short stature: children with growth hormone deficiency; short stature in children small for gestational age; short stature due to chronic diseases; idiopathic short stature; 3. Patients who are clinically diagnosed as ASD, meet the diagnostic criteria for ASD in the American Diagnostic Manual of Mental Disorders DSM-5; and the Autism Diagnostic Observation Interview-2 Version (ADOS-2) is positive; 4. The subject's legal guardian agrees to the treatment and signs the project's informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal liver and kidney function and blood sugar; 2. Patients with abnormal hematuria metabolism (such as congenital hypothyroidism, phenylketonuria, etc.); 3. Diagnosed tumor or high risk of tumor, high tumor risk syndrome (Bloom syndrome, Fanconi syndrome, Down syndrome, etc.); 4. Those who are highly allergic or allergic to the research drug; 5. Those who are accompanied by epilepsy and other chronic diseases and are receiving chronic disease drug treatment; 6. High-dose vitamin D3 supplements (>=2000 units/day); 7. Unwilling to be followed up or poor treatment compliance; 8. Are participating in other clinical investigators, or have participated in other clinical investigators within 3 months of enrollment; 9. Other conditions deemed inappropriate by the investigator.

Design outcomes

Primary

Measure	Time frame
the Chinese version of GMDS;the Chinese version of ADOS-2;	—

Secondary

Measure	Time frame
Autism Behavior Scale;Childhood Autism Rating Scale;Height;Weight;Head circumference;	—

Countries

China

Contacts

Public ContactJia Feiyong

The First Hospital of Jilin University

jiafy@jlu.edu.cn+86 431 88783846

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026