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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02389803
Other study ID # rmc067614ctil
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date February 1, 2021

Study information

Verified date December 2019
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 10 Years to 15 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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 )
Placebo comparator
Low caloric formula (Powder added to water), without added vitamins and minerals

Locations

Country Name City State
Israel Soroka Medical Center Be'er Sheva'
Israel Schneider Medical Center Petach- Tikva
Israel Assaf Harofe Medical Center Rishon Letsiyon

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to puberty initiation (Duration of time until testicular volume is at tanner stage >=2) Duration of time until testicular volume is at tanner stage >=2 At 12 months
Other Sleep assessment Questionnaire At 12 Months
Other Sleep assessment Questionnaire At 6 Months
Other Physical Activity Questionnaire At 12 months
Other Study Participation Questionnaire At 6 months
Other Study Participation Questionnaire At 12 months
Other Family Eating and Activity Habits Questionnaire At 6 months
Other Family Eating and Activity Habits Questionnaire At 12 months
Other Parents Stands Towards Healthy Lifestyle Questionnaire At 6 months
Other Parents Stands Towards Healthy Lifestyle Questionnaire At 12 months
Primary Weight SDS (standard deviation score) At 12 months
Primary Height SDS (standard deviation score) At 12 months
Primary Weight SDS (standard deviation score) At 6 months
Primary Height SDS (standard deviation score) At 6 months
Secondary BMI SDS (standard deviation score) At 12 months
Secondary BMI SDS (standard deviation score) At 6 months
Secondary Growth velocity At 12 months
Secondary Growth velocity At 6 months
Secondary Quality of life Quality of life measured by Quality of Life Questionnaire At 12 months
Secondary Quality of life Quality of life measured by Quality of Life Questionnaire At 6 months
Secondary Self-esteem (Self-Esteem Questionnaire) Self-esteem measured by Self-Esteem Questionnaire At 12 months
Secondary Self-esteem (Self-Esteem Questionnaire) Self-esteem measured by Self-Esteem Questionnaire At 6 months
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