ISS- Idiopathic Short Stature
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTNutritional supplementation standardized formula
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_SUPPLEMENTPlacebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| height standard deviation score (SDS) | at 6 moths |
| weight standard deviation score | at 6 months |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| height SDS | at 12 months |
| BMI SDS | at 12 months |
| Weight SDS | at 12 months |
| Lean body mass | at 12 months |
| muscle mass | at 12 months |
| fat mass | at 12 months |
| fat mass percentage | at 12 months |
Countries
Israel
Contacts
Primary ContactMoshe Phillip, Prof.
Backup ContactAlonah Hamou, MSc
Outcome results
None listed