Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
- Conditions
- Low WeightGrowth Problem
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Nutritional supplementation standardized formula
- Registration Number
- NCT02397200
- Lead Sponsor
- Rabin Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo comparator Placebo Low caloric formula (Powder added to water), without added vitamins and minerals. Nutritional supplementation standardized formula Nutritional 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 )
- Primary Outcome Measures
Name Time Method Weight SDS (standard deviation score) At 6 months Standard deviation score of patient's weight at 6 months
Height SDS (standard deviation score) At 6 months Standard deviation score of patient's height at 6 months
- Secondary Outcome Measures
Name Time Method Quality of life Questionnaire At 6 months Quality of life measured by quality of life questionnaire
Self-esteem Questionnaire At 6 months Growth velocity At 6 months Growth velocity measured as delta height divided by 6 months
BMI SDS (standard deviation score) At 6 months Standard deviation score of patient's BMI at 6 months
Trial Locations
- Locations (3)
Soroka Medical Center
🇮🇱Be'er Sheva', Israel
Schneider Children's Medical Center
🇮🇱Petach-Tikva, Israel
Assaf Harofe
🇮🇱Rishon Letsiyon, Israel