Clinical trial NCT03323177: Long Term Effects of Nutritional Supplementation on Final Height
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth Disorders
Low Weight
Short Stature
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Final Height Standardized Deviation Score (SDS)
timeFrame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Secondary outcomes:
measure: Weight Standard Deviation Score
timeFrame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
measure: Body Mass Index (BMI) Standard Deviation Score
timeFrame: Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
measure: Duration of puberty
timeFrame: Up to 7 years (After reaching full puberty:tanner stage 5)
measure: Quality of Life
timeFrame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
measure: Self Esteem
timeFrame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
References: