The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached
Schneider Children's Medical Center
Petah Tikva, Israel
Final Height Standardized Deviation Score (SDS)
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Weight Standard Deviation Score
Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Body Mass Index (BMI) Standard Deviation Score
Time frame: Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Duration of puberty
Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Time frame: Up to 7 years (After reaching full puberty:tanner stage 5)
Quality of Life
Quality of life as measured through Quality of Life Questionnaire
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Self Esteem
Self Esteem as measured through Self Esteem Questionnaire
Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
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