Long Term Effects of Nutritional Supplementation on Final Height

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys

NCT02389803

Growth Problem Low Weight Short Stature

COMPLETED NA

Study to Evaluate the Effect of Short Treatment With Nutritional Supplementation Standardized Innovative Formula, on Growth and Weight Gain in Short and Lean Prepubertal Children

NCT01158352

Growth Low Weight Low Height

COMPLETED NA

The Effect of Nutritional Formula Supplementation on Linear Growth of Growth Hormone (GH) Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy

NCT04962360

ISS- Idiopathic Short Stature

RECRUITING NA

Effect of Nutritional Formula Supplementation on Growth Rate of Growth Hormone (GH) Treated Children With Growth Hormone Deficiency (GHD) After the Second Year of Therapy

NCT03053687

IGHD - Isolated Growth Hormone Deficiency Growth Retardation

RECRUITING NA

Short Stature Related Distress

NCT01246219

Idiopathic Short Stature Self Image

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Disorders Low Weight Short Stature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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