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

Launched by RABIN MEDICAL CENTER · Feb 12, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a special nutritional formula to the treatment of children with Isolated Growth Hormone Deficiency (IGHD) can help them grow better after they have been receiving Growth Hormone (GH) treatment for at least two years. The trial involves 64 children who will be divided into two groups: one group will receive the nutritional formula alongside their usual GH treatment, while the other group will receive a placebo, which is a harmless powder that looks like the formula but does not have any active ingredients. This study will last for 6 months, and participants will have the option to continue for another 6 months after that.

To be eligible for this trial, children need to be between the ages of about 3 to 14 years and must have been on GH treatment for at least two years. They also need to have a confirmed diagnosis of IGHD and meet certain health criteria, such as having a specific body weight and growth measurements. Throughout the trial, both the participants and the study team will not know which group the children are in, ensuring that the results are fair and unbiased. This study aims to help improve growth outcomes for children with this condition, and families interested in participating will need to provide informed consent before joining.

Gender

ALL

Eligibility 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