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RecruitingAccepts healthy volunteersPhase 3

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

Northwell Health · NCT06103513

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 5–15 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
50
US sites recruiting
1
Study start
December 10, 2023
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Somatropin

Conditions: Growth Disorders; Growth Failure; Growth Hormone Treatment; Growth

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 5-15 years
  • In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
  • 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.

Recruiting US locations

  • Northwell Health

    New York, NY 11042

    Site contact: Neetu Vashistha, MA · 516-472-3631 · nvashistha@northwell.edu

Study contacts (from the official record)

  • Namma Pollack-Schreiber, MD · 516-472-3750 · NPollackschr@northwell.edu
  • Ishrat Ghani · 5164723692 · Ighani@northwell.edu
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Randomized Clinical Trial of Two Different Initial Growth Hormone… (NCT06103513) | Bored Studies