Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls

Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls

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

Study Overview

• Status: Completed
• Conditions: Low Weight; Growth Problem
• Intervention / Treatment: Dietary supplement: Nutritional supplementation standardized formula; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva', Israel
    • Soroka Medical Center
  • Petach-Tikva, Israel, 49202
    • Schneider Children's Medical Center
  • Rishon Letsiyon, Israel
    • Assaf Harofe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 )	Dietary supplement: Nutritional 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 )
Placebo Comparator: Placebo comparator; Low caloric formula (Powder added to water), without added vitamins and minerals.	Dietary supplement: Placebo; Low caloric formula (Powder added to water), without added vitamins and minerals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight SDS (standard deviation score)	Standard deviation score of patient's weight at 12 months	At 12 months
Height SDS (standard deviation score)	Standard deviation score of patient's height at 12 months	At 12 months
Weight SDS (standard deviation score)	Standard deviation score of patient's weight at 6 months	At 6 months
Height SDS (standard deviation score)	Standard deviation score of patient's height at 6 months	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI SDS (standard deviation score)	Standard deviation score of patient's BMI at 12 months	At 12 months
BMI SDS (standard deviation score)	Standard deviation score of patient's BMI at 6 months	At 6 months
Growth velocity	Growth velocity measured as delta height divided by 12 months	At 12 months
Growth velocity	Growth velocity measured as delta height divided by 6 months	At 6 months
Quality of life Questionnaire	Quality of life measured by quality of life questionnaire	At 12 months
Quality of life Questionnaire	Quality of life measured by quality of life questionnaire	At 6 months
Self-esteem Questionnaire		At 12 months
Self-esteem Questionnaire		At 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Questionnaire		At 12 months
Study Participation Questionnaire		At 6 months
Study Participation Questionnaire		At 12 months
Family Eating and Activity Habits Questionnaire		At 6 months
Family Eating and Activity Habits Questionnaire		At 12 months
Time to puberty initiation	Duration of time until breast at tanner stage >=2	At 12 months
Sleep Assessment Questionnaire		At 6 months
Sleep Assessment Questionnaire		At 12 months
Physical Activity Questionnaire		At 6 months
Parents Stands Towards Healty Lifestyle Questionnaire		At 12 months
Parents Stands Towards Healty Lifestyle Questionnaire		At 6 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Moshe Phillip, Prof, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: February 24, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimated): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Growth; Nutritional Supplementation; low weight; low height
• Other Study ID Numbers: rmc000214ctil