Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys

Conditions
-----------------
Growth Problem, Low Weight, Short Stature

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys aged ≥10years old Prepubertal - Tanner stage 1 (gonadarche) (testicular volume<4) Height and weight ≤ 10th percentile for age and gender. Height-SDS ≥ -2.5 SDS BMI-SDS>-3 SDS Low proportion between weight and height Signing inform consent forms Exclusion Criteria: Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems Any known gastrointestinal disease including malabsorption Any known organic reason for growth retardation

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 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 multi vitamin 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 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 )<br>|
| Placebo Comparator: Placebo comparator<br>Low caloric formula (Powder added to water), without added vitamins and mineral | Dietary Supplement: Placebo comparator<br>* Low caloric formula (Powder added to water), without added vitamins and minerals<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI SDS (standard deviation score) |  | At 12 months | 
| BMI SDS (standard deviation score) |  | At 6 months | 
| Growth velocity |  | 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 |