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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional standardized supplementation formula. | Experimental | 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. |
|
| Placebo | Placebo Comparator | Low caloric formula (Powder added to water) without added vitamins and minerals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplementation standardized formula | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| height standard deviation score (SDS) | at 6 moths | |
| weight standard deviation score | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI SDS | at 6 months | |
| Lean body mass | at 6 months | |
| muscle mass |
| Measure | Description | Time Frame |
|---|---|---|
| height SDS | at 12 months | |
| Weight SDS | at 12 months | |
| BMI SDS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moshe Phillip, Prof. | Contact | 972-3-9253282 | mosheph@clalit.org.il | |
| Alonah Hamou, MSc | Contact | 972-39253747 | alonah@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Schnieder Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider children's medical center | Recruiting | Petah Tikva | Israel |
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|
| Placebo | Dietary Supplement | Low caloric formula (Powder added to water) without added vitamins and minerals |
|
| at 6 months |
| Fat mass | at 6 months |
| Fat mass percentage | at 6 months |
| 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 |