Growth Disorders, Low Weight, Short Stature
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGender specific nutritional standardized formula
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
OTHERFollow-up only
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
Sponsors
Rabin Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 7 years (After reaching full puberty:tanner stage 5) | Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5 |
| Quality of Life | Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year) | Quality of life as measured through Quality of Life Questionnaire |
| Self Esteem | Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year) | Self Esteem as measured through Self Esteem Questionnaire |
Countries
Israel
Outcome results
None listed