Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
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
Inclusion Criteria:

 -  Girls aged ≥9 years old

 -  Prepubertal - Tanner stage 1. (gonadarche) Breast at Tanner stage 1)

 -  Height and weight ≤ 10th percentile for age and gender.

 -  Height-SDS ≥ -2.5 SDS

 -  BMI-SDS>-2 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

 -  Any chronic treatment with medication that might affect appetite, weight or growth
 (for example SSRI's).