Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Primary Purpose
Growth Problem, Low Weight, Short Stature
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nutritional supplementation standardized formula
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Growth Problem
Eligibility Criteria
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
Sites / Locations
- Soroka Medical Center
- Schneider Medical Center
- Assaf Harofe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nutritional supplementation standardized formula
Placebo comparator
Arm Description
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 )
Low caloric formula (Powder added to water), without added vitamins and mineral
Outcomes
Primary Outcome Measures
Weight SDS (standard deviation score)
Height SDS (standard deviation score)
Weight SDS (standard deviation score)
Height SDS (standard deviation score)
Secondary Outcome Measures
BMI SDS (standard deviation score)
BMI SDS (standard deviation score)
Growth velocity
Growth velocity
Quality of life
Quality of life measured by Quality of Life Questionnaire
Quality of life
Quality of life measured by Quality of Life Questionnaire
Self-esteem (Self-Esteem Questionnaire)
Self-esteem measured by Self-Esteem Questionnaire
Self-esteem (Self-Esteem Questionnaire)
Self-esteem measured by Self-Esteem Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02389803
Brief Title
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Official Title
Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Problem, Low Weight, Short Stature
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional supplementation standardized formula
Arm Type
Experimental
Arm Description
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 )
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
Low caloric formula (Powder added to water), without added vitamins and mineral
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional supplementation standardized formula
Intervention Description
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 )
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo comparator
Intervention Description
Low caloric formula (Powder added to water), without added vitamins and minerals
Primary Outcome Measure Information:
Title
Weight SDS (standard deviation score)
Time Frame
At 12 months
Title
Height SDS (standard deviation score)
Time Frame
At 12 months
Title
Weight SDS (standard deviation score)
Time Frame
At 6 months
Title
Height SDS (standard deviation score)
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
BMI SDS (standard deviation score)
Time Frame
At 12 months
Title
BMI SDS (standard deviation score)
Time Frame
At 6 months
Title
Growth velocity
Time Frame
At 12 months
Title
Growth velocity
Time Frame
At 6 months
Title
Quality of life
Description
Quality of life measured by Quality of Life Questionnaire
Time Frame
At 12 months
Title
Quality of life
Description
Quality of life measured by Quality of Life Questionnaire
Time Frame
At 6 months
Title
Self-esteem (Self-Esteem Questionnaire)
Description
Self-esteem measured by Self-Esteem Questionnaire
Time Frame
At 12 months
Title
Self-esteem (Self-Esteem Questionnaire)
Description
Self-esteem measured by Self-Esteem Questionnaire
Time Frame
At 6 months
Other Pre-specified Outcome Measures:
Title
Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2)
Description
Duration of time until testicular volume is at tanner stage >=2
Time Frame
At 12 months
Title
Sleep assessment Questionnaire
Time Frame
At 12 Months
Title
Sleep assessment Questionnaire
Time Frame
At 6 Months
Title
Physical Activity Questionnaire
Time Frame
At 12 months
Title
Study Participation Questionnaire
Time Frame
At 6 months
Title
Study Participation Questionnaire
Time Frame
At 12 months
Title
Family Eating and Activity Habits Questionnaire
Time Frame
At 6 months
Title
Family Eating and Activity Habits Questionnaire
Time Frame
At 12 months
Title
Parents Stands Towards Healthy Lifestyle Questionnaire
Time Frame
At 6 months
Title
Parents Stands Towards Healthy Lifestyle Questionnaire
Time Frame
At 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Schneider Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Be'er Sheva'
Country
Israel
Facility Name
Schneider Medical Center
City
Petach- Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Assaf Harofe Medical Center
City
Rishon Letsiyon
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
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