Effect of Nutritional Formula on Growth in Children Treated with Growth Hormone
The Effect of Nutritional Formula Supplementation on Linear Growth of GH Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy: a Randomized, Double- Blind, Placebo-controlled Trial
This study is testing whether adding a special nutritional formula can help children with growth issues who are already getting growth hormone treatment grow better over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 5 Years to 10 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petah tikva) |
| Trial ID | NCT04962360 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of nutritional formula supplementation on the growth of prepubertal children diagnosed with Idiopathic Short Stature (ISS) who have been receiving growth hormone (GH) therapy for two years. It is a double-blind, randomized, placebo-controlled trial involving 64 participants, who will be assigned to either the nutritional intervention group or a placebo group. The study will last for six months, with an additional six-month extension period to assess long-term effects. Both participants and researchers will remain unaware of which treatment each child receives to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-10 years with ISS who have been on GH treatment for at least 24 months.
Not a fit: Patients with growth hormone deficiency or significant chronic health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance growth outcomes in children with ISS undergoing GH therapy.
How similar studies have performed: While there have been studies on GH therapy, the specific combination with nutritional supplementation in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. GH treatment for at least 24 months due to idiopathic short stature (ISS) 2. Age 5-10 years inclusive. 3. Tanner stage 1 (gonadarche). 4. BMI \<85 percentile for age and gender. Exclusion Criteria: 1. SGA/ IUGR 2. Diagnosis of GH deficiency 3. Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardial, renal or pulmonary problems, metabolic disorders. 4. Any known gastrointestinal problem including absorption problems. 5. Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids). 6. Any eating disorders and/or psychiatric disorder 7. Milk or other food allergies
Where this trial is running
Petah tikva
- Schneider children's medical center — Petah tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Moshe Phillip, Prof — Schnieder Children's Medical Center
- Study coordinator: Moshe Phillip, Prof.
- Email: mosheph@clalit.org.il
- Phone: 972-3-9253282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.