Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 female 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 female 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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplementation standardized formula | Experimental | 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 ) |
|
| Placebo comparator | 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 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) | Standard deviation score of patient's weight at 12 months | At 12 months |
| Height SDS (standard deviation score) | Standard deviation score of patient's height at 12 months | At 12 months |
| Weight SDS (standard deviation score) | Standard deviation score of patient's weight at 6 months | At 6 months |
| Height SDS (standard deviation score) | Standard deviation score of patient's height at 6 months | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| BMI SDS (standard deviation score) | Standard deviation score of patient's BMI at 12 months | At 12 months |
| BMI SDS (standard deviation score) | Standard deviation score of patient's BMI at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to puberty initiation | Duration of time until breast at tanner stage >=2 | At 12 months |
| Sleep Assessment Questionnaire | At 6 months | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 Children's Medical Center |
Not provided
| ID | Term |
|---|---|
| D013851 | Thinness |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Dietary Supplement | Low caloric formula (Powder added to water), without added vitamins and minerals |
|
| At 6 months |
| Growth velocity | Growth velocity measured as delta height divided by 12 months | At 12 months |
| Growth velocity | Growth velocity measured as delta height divided by 6 months | At 6 months |
| Quality of life Questionnaire | Quality of life measured by quality of life questionnaire | At 12 months |
| Quality of life Questionnaire | Quality of life measured by quality of life questionnaire | At 6 months |
| Self-esteem Questionnaire | At 12 months |
| Self-esteem Questionnaire | At 6 months |
| Sleep Assessment Questionnaire |
| At 12 months |
| Physical Activity 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 Healty Lifestyle Questionnaire | At 12 months |
| Parents Stands Towards Healty Lifestyle Questionnaire | At 6 months |
| Petah Tikva |
| 49202 |
| Israel |
| Assaf Harofe | Rishon LeZiyyon | Israel |