Growth Clinical Trial
Official title:
A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 10, 2025 |
Est. primary completion date | June 10, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 15 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annualized Growth Velocity (GV) in the first year after treatment | Height (cm) at 0- month visit; height (cm) at 12-month visit | I year | |
Secondary | IGF1- 0,4,8,12 months | IGF-1 will be collected at timepoints - 0,4,8,12 months | 12 Months | |
Secondary | IGFBP3 - 0,4,8,12 months | IGFBP3 will be collected at timepoints - 0,4,8,12 months | 12 Months | |
Secondary | HbA1c - 4,8,12 months | HbA1c will be collected at timepoints 4,8,12 months | 12 Months | |
Secondary | Total T4 or Free T4 - 0,12 months | Total T4 or Free T4 will be collected at timepoints 0,12 months | 12 Months | |
Secondary | TSH - 0, 12 months | TSH will be collected at timepoints 0, 12 months | 12 Months |
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