Clinical trial NCT02389803: Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Official title: Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Problem
Low Weight
Short Stature
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 160
Sex: MALE
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design:

Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1.

The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo


Eligibility criteria: Inclusion Criteria:

* Boys aged ≥10years old
* Prepubertal - Tanner stage 1 (gonadarche) (testicular volume\<4)
* Height and weight ≤ 10th percentile for age and gender.
* Height-SDS ≥ -2.5 SDS
* BMI-SDS\>-3 SDS
* Low proportion between weight and height
* Signing inform consent forms

Exclusion Criteria:

* Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
* 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

Primary outcomes:
measure: Weight SDS (standard deviation score)
timeFrame: At 12 months
measure: Height SDS (standard deviation score)
timeFrame: At 12 months
measure: Weight SDS (standard deviation score)
timeFrame: At 6 months
measure: Height SDS (standard deviation score)
timeFrame: At 6 months
Secondary outcomes:
measure: BMI SDS (standard deviation score)
timeFrame: At 12 months
measure: BMI SDS (standard deviation score)
timeFrame: At 6 months
measure: Growth velocity
timeFrame: At 12 months
measure: Growth velocity
timeFrame: At 6 months
measure: Quality of life
timeFrame: At 12 months
measure: Quality of life
timeFrame: At 6 months
measure: Self-esteem (Self-Esteem Questionnaire)
timeFrame: At 12 months
measure: Self-esteem (Self-Esteem Questionnaire)
timeFrame: At 6 months
Other outcomes:
measure: Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2)
timeFrame: At 12 months
measure: Sleep assessment Questionnaire
timeFrame: At 12 Months
measure: Sleep assessment Questionnaire
timeFrame: At 6 Months
measure: Physical Activity Questionnaire
timeFrame: At 12 months
measure: Study Participation Questionnaire
timeFrame: At 6 months
measure: Study Participation Questionnaire
timeFrame: At 12 months
measure: Family Eating and Activity Habits Questionnaire
timeFrame: At 6 months
measure: Family Eating and Activity Habits Questionnaire
timeFrame: At 12 months
measure: Parents Stands Towards Healthy Lifestyle Questionnaire
timeFrame: At 6 months
measure: Parents Stands Towards Healthy Lifestyle Questionnaire
timeFrame: At 12 months
Locations:
city: Be'er Sheva'
country: Israel
facility: Soroka Medical Center
city: Petach- Tikva
country: Israel
facility: Schneider Medical Center
city: Rishon Letsiyon
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: