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

Short Stature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389803
• Other study ID #: rmc067614ctil
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dwarfism
• Growth Problem
• Low Weight
• Short Stature

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