Long Term Effects of Nutritional Supplementation on Final Height

Long Term Effects of Nutritional Supplementation on Final Height of Short and Lean Adolescents: Follow-up Study to One-year Double-blind, Randomized, Placebo Controlled Studies to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescent Boys and Girls

The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.

Study Overview

• Status: Withdrawn
• Conditions: Growth Disorders; Low Weight; Short Stature
• Intervention / Treatment: Dietary supplement: Gender specific nutritional standardized formula; Other: Follow-up only

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15).
• Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15)
• Signing informed consent forme

Exclusion Criteria:

• Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone
• 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
• Any chronic treatment with medication that might affect appetite, weight or growth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional supplementation gender specific formula; Patients at this arm will continue to consume the study formula until final height. The formula is a gender specific 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 (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake	Dietary supplement: Gender specific nutritional standardized formula; Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
Other: Follow-up only; Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached	Other: Follow-up only; Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Final Height Standardized Deviation Score (SDS)	Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Standard Deviation Score		Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
Body Mass Index (BMI) Standard Deviation Score		Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
Duration of puberty	Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5	Up to 7 years (After reaching full puberty:tanner stage 5)
Quality of Life	Quality of life as measured through Quality of Life Questionnaire	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
Self Esteem	Self Esteem as measured through Self Esteem Questionnaire	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Growth Disorders; Dwarfism
• Other Study ID Numbers: RMC025117ctil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No