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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Rabin Medical Center
- Locations
- 2
- Primary Endpoint
- Final Height Standardized Deviation Score (SDS)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Final Height Standardized Deviation Score (SDS)
Time Frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary Outcomes
- Duration of puberty(Up to 7 years (After reaching full puberty:tanner stage 5))
- Quality of Life(Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year))
- Self Esteem(Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year))
- 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))