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Long Term Effects of Nutritional Supplementation on Final Height

NCT ID: NCT03323177

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-06-30

Brief Summary

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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

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Conditions

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Growth Disorders Low Weight Short Stature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Gender specific nutritional standardized formula

Intervention Type DIETARY_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 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

Group Type OTHER

Follow-up only

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RMC025117ctil

Identifier Type: -

Identifier Source: org_study_id