Comparing two doses of growth hormone in children with growth deficiency
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
Run by Northwell Health · NCT06103513 · Data updated 2026-11-12
This study is testing whether a higher or lower dose of growth hormone helps children with growth deficiency grow taller and stay safe during treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years to 15 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | December 10, 2023 |
| Main results expected | January 5, 2028 |
| Study ends | January 5, 2028 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT06103513 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 5 to 15 years who have been diagnosed with growth hormone deficiency and are in good general health.
✕Probably not a fit
Patients with growth hormone resistance, syndromic short stature, active malignancies, or systemic illnesses such as heart or kidney failure may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective, randomized, open-label study involving 50 children aged 5 to 15 years diagnosed with growth hormone deficiency. Participants will be divided into two groups, with one group receiving a higher dose of growth hormone (0.3 mg/kg/week) and the other receiving a lower dose (0.2 mg/kg/week) for the first year of treatment. The study will assess safety, height velocity, and predictions of adult height based on bone age at four-month intervals over the course of the year. The goal is to determine the optimal initial dose for effective treatment.
Why it matters
Potential benefit: If successful, this study could help identify the most effective initial dose of growth hormone, leading to improved growth outcomes for children with growth hormone deficiency.
How similar studies have gone: Other studies have explored growth hormone dosing, but this specific comparison of two initial doses in a randomized format is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Northwell Health
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Benjamin U. Nwosu, MD — Northwell Health, INC.
- Study coordinator: Namma Pollack-Schreiber, MD
- Email: NPollackschr@northwell.edu
- Phone: 516-472-3750
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.