The Effect of Nutritional Formula Supplementation on Linear Growth of Growth Hormone (GH) Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy

Study Overview
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Brief Summary
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The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of combined growth hormone (GH) treatment &nutritional formula supplementation versus GH & placebo on growth parameters in 64 children with Idiopathic Short Stature (ISS) after the second year of GH treatment. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender. Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.

Official Title
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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

Conditions
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ISS- Idiopathic Short Stature

Intervention / Treatment
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* Dietary Supplement: Nutritional supplementation standardized formula
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GH treatment for at least 24 months due to idiopathic short stature (ISS) Age 5-10 years inclusive. Tanner stage 1 (gonadarche). BMI <85 percentile for age and gender. Exclusion Criteria: SGA/ IUGR Diagnosis of GH deficiency 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. Any known gastrointestinal problem including absorption problems. Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids). Any eating disorders and/or psychiatric disorder Milk or other food allergies

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional standardized supplementation formula.<br>Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake. | Dietary Supplement: Nutritional supplementation standardized formula<br>* Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake<br>|
| Placebo Comparator: Placebo<br>Low caloric formula (Powder added to water) without added vitamins and minerals | Dietary Supplement: Placebo<br>* Low caloric formula (Powder added to water) without added vitamins and minerals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height standard deviation score (SDS) |  | at 6 moths | 
| weight standard deviation score |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI SDS |  | at 6 months | 
| Lean body mass |  | at 6 months | 
| muscle mass |  | at 6 months | 
| Fat mass |  | at 6 months | 
| Fat mass percentage |  | at 6 months |