Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

Launched by NORTHWELL HEALTH · Oct 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different starting doses of growth hormone treatment in children who have growth hormone deficiency, which means their bodies don’t produce enough growth hormone for normal growth. The trial involves 50 children, ages 5 to 15, who will be randomly assigned to receive either a higher dose of 0.3 mg/kg/week or a lower dose of 0.2 mg/kg/week for the first year. The researchers will check the children's growth and overall safety every four months during this time.

To participate in the study, children must be generally healthy or diagnosed with growth hormone deficiency, and their parents or guardians must agree to the study rules. They will need to be able to receive nightly injections of the growth hormone. However, children with certain conditions, like specific genetic syndromes or serious illnesses, won't be eligible. This trial aims to better understand how different doses affect growth, which could help doctors determine the best treatment approaches for children with growth issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated informed consent form
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 3. Male or female, aged 5-15 years
• • 4. In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
• • 5. Ability to take subcutaneous GH injections nightly
• Exclusion Criteria:
• • Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.