Growth Problem, Low Weight, Short Stature
Conditions
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
Interventions
DIETARY_SUPPLEMENTPlacebo comparator
Low caloric formula (Powder added to water), without added vitamins and minerals
DIETARY_SUPPLEMENTNutritional supplementation standardized formula
Powder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake )
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
10 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight SDS (standard deviation score) | At 12 months |
| Height SDS (standard deviation score) | At 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI SDS (standard deviation score) | At 12 months | — |
| Growth velocity | At 12 months | — |
| Quality of life | At 12 months | Quality of life measured by Quality of Life Questionnaire |
| Self-esteem (Self-Esteem Questionnaire) | At 12 months | Self-esteem measured by Self-Esteem Questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2) | At 12 months | Duration of time until testicular volume is at tanner stage \>=2 |
| Sleep assessment Questionnaire | At 12 Months | — |
| Physical Activity Questionnaire | At 12 months | — |
| Study Participation Questionnaire | At 6 months | — |
| Family Eating and Activity Habits Questionnaire | At 6 months | — |
| Parents Stands Towards Healthy Lifestyle Questionnaire | At 6 months | — |
Countries
Israel
Outcome results
None listed