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Long Term Effects of Nutritional Supplementation on Final Height

NCT03323177 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-12-27

No results posted yet for this study

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.

Conditions

  • Growth Disorders
  • Low Weight
  • Short Stature

Interventions

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

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323177 on ClinicalTrials.gov