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

Not Applicable

Completed

• Conditions: Short Stature; Growth Problem; Low Weight
• Interventions: Dietary Supplement: Placebo comparator; Dietary Supplement: Nutritional supplementation standardized formula

• Registration Number: NCT02389803
• Lead Sponsor: Rabin Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-17
• Study Start: 2015-06
• Status Verified: 2019-12
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator	Placebo comparator	Low caloric formula (Powder added to water), without added vitamins and mineral
Nutritional supplementation standardized formula	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 )

Primary Outcome Measures

Name	Time	Method
Weight SDS (standard deviation score)	At 6 months
Height SDS (standard deviation score)	At 6 months

Secondary Outcome Measures

Name	Time	Method
BMI SDS (standard deviation score)	At 6 months
Growth velocity	At 6 months
Self-esteem (Self-Esteem Questionnaire)	At 6 months	Self-esteem measured by Self-Esteem Questionnaire
Quality of life	At 6 months	Quality of life measured by Quality of Life Questionnaire

Trial Locations

Locations (3)

Schneider Medical Center; 🇮🇱 Petach- Tikva, Israel

Soroka Medical Center; 🇮🇱 Be'er Sheva', Israel

Assaf Harofe Medical Center; 🇮🇱 Rishon Letsiyon, Israel