Long Term Effects of Nutritional Supplementation on Final Height

Study Overview
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Brief Summary
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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.

Official Title
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Long Term Effects of Nutritional Supplementation on Final Height of Short and Lean Adolescents: Follow-up Study to One-year Double-blind, Randomized, Placebo Controlled Studies to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescent Boys and Girls

Conditions
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Growth Disorders, Low Weight, Short Stature

Intervention / Treatment
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* Dietary Supplement: Gender specific nutritional standardized formula
* Other: Follow-up only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15). Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15) Signing informed consent forme Exclusion Criteria: Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone 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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional supplementation gender specific formula<br>Patients at this arm will continue to consume the study formula until final height. The formula is a gender specific 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 (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake | Dietary Supplement: Gender specific nutritional standardized formula<br>* 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<br>|
| Other: Follow-up only<br>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 | Other: Follow-up only<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Height Standardized Deviation Score (SDS) |  | Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Standard Deviation Score |  | Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year) | 
| Body Mass Index (BMI) Standard Deviation Score |  | 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 | Up to 7 years (After reaching full puberty:tanner stage 5) | 
| Quality of Life | Quality of life as measured through Quality of Life Questionnaire | 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 | Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year) |