Long Term Effects of Nutritional Supplementation on Final Height

Not Applicable

Withdrawn

• Conditions: Short Stature; Low Weight; Growth Disorders
• Interventions: Other: Follow-up only; Dietary Supplement: Gender specific nutritional standardized formula

• Registration Number: NCT03323177
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Status Verified: 2018-04
• Study Start: 2018-06
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Follow-up only	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
Nutritional supplementation gender specific formula	Gender specific nutritional standardized 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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of puberty	Up to 7 years (After reaching full puberty:tanner stage 5)	Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
Quality of Life	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)	Quality of life as measured through Quality of Life Questionnaire
Self Esteem	Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)	Self Esteem as measured through Self Esteem Questionnaire
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)

Trial Locations

Locations (1)

Schneider Children's Medical Center; 🇮🇱 Petach-Tikva, Israel