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

March 25, 2024 updated by: Rabin Medical Center

The Effect of Nutritional Formula Supplementation on Linear Growth of GH Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy: a Randomized, Double- Blind, Placebo-controlled Trial

The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of combined growth hormone (GH) treatment &nutritional formula supplementation versus GH & placebo on growth parameters in 64 children with Idiopathic Short Stature (ISS) after the second year of GH treatment.

Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. The randomization will be done according to gender.

Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Petah tikva, Israel
        • Recruiting
        • Schneider Children's Medical Center
        • Contact:
        • Sub-Investigator:
          • Naama Fish, Dr
        • Sub-Investigator:
          • Liora Lazar, Prof
        • Sub-Investigator:
          • Sharon Demol, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. GH treatment for at least 24 months due to idiopathic short stature (ISS)
  2. Age 5-10 years inclusive.
  3. Tanner stage 1 (gonadarche).
  4. BMI <85 percentile for age and gender.

Exclusion Criteria:

  1. SGA/ IUGR
  2. Diagnosis of GH deficiency
  3. Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardial, renal or pulmonary problems, metabolic disorders.
  4. Any known gastrointestinal problem including absorption problems.
  5. Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids).
  6. Any eating disorders and/or psychiatric disorder
  7. Milk or other food allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional standardized supplementation formula.
Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake.
Dietary supplement: Nutritional supplementation standardized formula
Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
Placebo Comparator: Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Dietary supplement: Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight standard deviation score
Time Frame: at 6 months
at 6 months
height standard deviation score (SDS)
Time Frame: at 6 moths
at 6 moths

Secondary Outcome Measures

Outcome Measure
Time Frame
BMI SDS
Time Frame: at 6 months
at 6 months
Lean body mass
Time Frame: at 6 months
at 6 months
muscle mass
Time Frame: at 6 months
at 6 months
Fat mass
Time Frame: at 6 months
at 6 months
Fat mass percentage
Time Frame: at 6 months
at 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Weight SDS
Time Frame: at 12 months
at 12 months
BMI SDS
Time Frame: at 12 months
at 12 months
height SDS
Time Frame: at 12 months
at 12 months
Lean body mass
Time Frame: at 12 months
at 12 months
muscle mass
Time Frame: at 12 months
at 12 months
fat mass
Time Frame: at 12 months
at 12 months
fat mass percentage
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Moshe Phillip, Prof, Schnieder Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 4, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc26021ctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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