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Study design:
Double blind, randomized, placebo controlled study. 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.
The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 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 study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplementation standardized formula | Experimental | Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ) |
|
| Placebo comparator | Placebo Comparator | Low caloric formula (Powder added to water), without added vitamins and mineral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplementation standardized formula | Dietary Supplement | Powder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ) |
| Measure | Description | Time Frame |
|---|---|---|
| Weight SDS (standard deviation score) | At 12 months | |
| Height SDS (standard deviation score) | At 12 months | |
| Weight SDS (standard deviation score) | At 6 months | |
| Height SDS (standard deviation score) | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI SDS (standard deviation score) | At 12 months | |
| BMI SDS (standard deviation score) | At 6 months | |
| Growth velocity |
| Measure | Description | Time Frame |
|---|---|---|
| Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2) | Duration of time until testicular volume is at tanner stage >=2 | At 12 months |
| Sleep assessment Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Schneider Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel | ||||
| Schneider Medical Center |
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| ID | Term |
|---|---|
| D013851 | Thinness |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001848 | Bone Diseases, Developmental |
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|
| Placebo comparator | Dietary Supplement | Low caloric formula (Powder added to water), without added vitamins and minerals |
|
| At 12 months |
| Growth velocity | At 6 months |
| Quality of life | Quality of life measured by Quality of Life Questionnaire | At 12 months |
| Quality of life | Quality of life measured by Quality of Life Questionnaire | At 6 months |
| Self-esteem (Self-Esteem Questionnaire) | Self-esteem measured by Self-Esteem Questionnaire | At 12 months |
| Self-esteem (Self-Esteem Questionnaire) | Self-esteem measured by Self-Esteem Questionnaire | At 6 months |
| At 12 Months |
| Sleep assessment Questionnaire | At 6 Months |
| Physical Activity Questionnaire | At 12 months |
| Study Participation Questionnaire | At 6 months |
| Study Participation Questionnaire | At 12 months |
| Family Eating and Activity Habits Questionnaire | At 6 months |
| Family Eating and Activity Habits Questionnaire | At 12 months |
| Parents Stands Towards Healthy Lifestyle Questionnaire | At 6 months |
| Parents Stands Towards Healthy Lifestyle Questionnaire | At 12 months |
| Petah Tikva |
| 49202 |
| Israel |
| Assaf Harofe Medical Center | Rishon LeZiyyon | Israel |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |