Growth Problem, Low Weight
Conditions
Keywords
Growth, low weight, low height, Nutritional Supplementation
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 female 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 female 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_SUPPLEMENTNutritional supplementation standardized formula
Powder added to water, containing about 25% of recommended Daily Recommended Intake (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 )
DIETARY_SUPPLEMENTPlacebo
Low caloric formula (Powder added to water), without added vitamins and minerals
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Girls aged ≥9 years old * Prepubertal - Tanner stage 1. (gonadarche) Breast at Tanner stage 1) * Height and weight ≤ 10th percentile for age and gender. * Height-SDS ≥ -2.5 SDS * BMI-SDS\>-2 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 * Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight SDS (standard deviation score) | At 12 months | Standard deviation score of patient's weight at 12 months |
| Height SDS (standard deviation score) | At 12 months | Standard deviation score of patient's height at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI SDS (standard deviation score) | At 12 months | Standard deviation score of patient's BMI at 12 months |
| Growth velocity | At 12 months | Growth velocity measured as delta height divided by 12 months |
| Quality of life Questionnaire | At 12 months | Quality of life measured by quality of life questionnaire |
| Self-esteem Questionnaire | At 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to puberty initiation | At 12 months | Duration of time until breast at tanner stage \>=2 |
| Sleep Assessment Questionnaire | At 6 months | — |
| Physical Activity Questionnaire | At 6 months | — |
| Study Participation Questionnaire | At 6 months | — |
| Family Eating and Activity Habits Questionnaire | At 6 months | — |
| Parents Stands Towards Healty Lifestyle Questionnaire | At 12 months | — |
Countries
Israel
Outcome results
None listed