NCT02389803

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

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

Conditions

• Growth Problem
• Low Weight
• Short Stature

Interventions

Type	Name	Description
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 )
DIETARY_SUPPLEMENT	Placebo comparator	Low caloric formula (Powder added to water), without added vitamins and minerals

Timeline

• Start date: 2015-06-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2015-03-17
• Last updated: 2022-02-22

Locations

3 sites across 1 country: Israel