Long Term Effects of Nutritional Supplementation on Final Height

Rabin Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Growth Disorders Low Weight Short Stature

Interventions

Gender specific nutritional standardized formulaDIETARY_SUPPLEMENT

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

Follow-up onlyOTHER

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

Final Height Standardized Deviation Score (SDS)

Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)

Secondary Outcomes

Weight Standard Deviation Score

Time frame: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)

Body Mass Index (BMI) Standard Deviation Score

Time frame: 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

Time frame: Up to 7 years (After reaching full puberty:tanner stage 5)

Quality of Life

Quality of life as measured through Quality of Life Questionnaire

Time frame: 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

Time frame: Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.