Clinical trial NCT02397200: Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
Official title: Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Problem
Low Weight
Keywords: Growth
low weight
low height
Nutritional Supplementation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 99
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 14
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 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


Eligibility criteria: 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).

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 Questionnaire
timeFrame: At 12 months
measure: Quality of life Questionnaire
timeFrame: At 6 months
measure: Self-esteem Questionnaire
timeFrame: At 12 months
measure: Self-esteem Questionnaire
timeFrame: At 6 months
Other outcomes:
measure: Time to puberty initiation
timeFrame: At 12 months
measure: Sleep Assessment Questionnaire
timeFrame: At 6 months
measure: Sleep Assessment Questionnaire
timeFrame: At 12 months
measure: Physical Activity 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 Healty Lifestyle Questionnaire
timeFrame: At 12 months
measure: Parents Stands Towards Healty Lifestyle Questionnaire
timeFrame: At 6 months
Locations:
city: Be'er Sheva'
country: Israel
facility: Soroka Medical Center
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Rishon Letsiyon
country: Israel
facility: Assaf Harofe
Study officials:
affiliation: Schneider Children's Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: