Nutritional formula's effect on growth in children with growth hormone deficiency
Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy- a Randomized Double Blind, Placebo Controlled Trial
This study is testing if adding a special nutritional formula to the treatment of children with growth hormone deficiency can help them grow better while they are already receiving growth hormone therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 3 Years to 14 Years |
| Sex | All |
| Sponsor | Rabin Medical Center Academic / other |
| Locations | 1 site (Petach-Tikva) |
| Trial ID | NCT03053687 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of nutritional formula supplementation on the growth rate of children diagnosed with Isolated Growth Hormone Deficiency (IGHD) who have been receiving growth hormone (GH) treatment for at least two years. It is a double-blind, randomized, placebo-controlled trial involving 64 participants, who will be assigned to either receive the nutritional formula or a placebo alongside their ongoing GH therapy. The randomization will consider gender and Tanner stage to ensure balanced groups. The primary focus is to assess growth parameters after the intervention period.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 years and older who have been on GH treatment for at least 24 months and meet specific growth and Tanner stage criteria.
Not a fit: Patients with other indications for GH treatment or those with significant comorbidities or gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance growth outcomes for children with growth hormone deficiency by optimizing their nutritional support.
How similar studies have performed: While there is limited information on similar studies, the combination of nutritional supplementation with GH therapy is a novel approach that has not been extensively tested in this specific population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml * Boys: testicular volume \< 8ml; Girls: breast ≤ Tanner 3 * weight SDS \< 0 * BMI SDS \< 50 precentile for age and gender * Signing inform consent forms Exclusion Criteria: * Other indication for GH treatment. * Bone age: boys\>13.5, girls\>11.5. * Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders. * Any known gastrointestinal problem including absorption problems. * Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use * Any eating disorders and/or psychiatric disorder
Where this trial is running
Petach-Tikva
- Schnider children's medical center — Petach-Tikva, Israel (Recruiting)
Study contacts
- Principal investigator: Moshe Phillip, Prof, MD — Schneider Children's Medical Center
- Study coordinator: Moshe Phillip, Prof, MD
- 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.