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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-03-26

No results posted yet for this study

Summary

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 Isolated Growth Hormone Deficiency (IGHD) after the 2nd year of GH treatment.

In this trial GH is a background treatment (non-investigational medicinal product. Participants may be treated with any of the commercial GH products approved in Israel for the indication of IGHD.

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 and tanner stage.

Participants in the intervention groups will be treated with the study formulas and participants in the control group will be treated with a placebo low caloric formulas (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.

Conditions

  • IGHD - Isolated Growth Hormone Deficiency
  • Growth Retardation

Interventions

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

DIETARY_SUPPLEMENT

Placebo

Low caloric formula (Powder added to water) without added vitamins and mineral

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, Prof, MD · Schneider Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2024-10-31
Completion
2024-10-31

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 NCT03053687 on ClinicalTrials.gov