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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

Primary Purpose

IGHD - Isolated Growth Hormone Deficiency, Growth Retardation

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Nutritional supplementation standardized formula

Placebo

About this trial

This is an interventional treatment trial for IGHD - Isolated Growth Hormone Deficiency

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml
Boys: testicular volume < 8ml; Girls: breast ≤ Tanner 3
weight SDS < 0
BMI SDS < 50 precentile for age and gender
Signing inform consent forms

Exclusion Criteria:

Other indication for GH treatment.
Bone age: boys>13.5, girls>11.5.
Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders.
Any known gastrointestinal problem including absorption problems.
Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use
Any eating disorders and/or psychiatric disorder

Sites / Locations

Schnider children's medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutritional Standardized Supplementation Formula

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight Standard Deviation Score (SDS)

Secondary Outcome Measures

Height-SDS

Weight SDS

BMI SDS

Full Information

NCT ID

NCT03053687

First Posted

February 7, 2017

Last Updated

March 15, 2023

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03053687

Brief Title

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

Official Title

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- a Randomized Double Blind, Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IGHD - Isolated Growth Hormone Deficiency, Growth Retardation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nutritional Standardized Supplementation Formula

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional supplementation standardized formula

Intervention Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Weight Standard Deviation Score (SDS)

Time Frame

at 6 months

Secondary Outcome Measure Information:

Title

Height-SDS

Time Frame

at 12 months

Title

Weight SDS

Time Frame

at 12 months

Title

BMI SDS

Time Frame

at 12 months

Other Pre-specified Outcome Measures:

Title

Body composition

Time Frame

at 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: GH treatment for at least 24 months due to IGHD. Confirmed diagnosis of GHD as determined by at least one GH stimulation test, defined as a peak GH level of ≤ 10 ng/ml Boys: testicular volume < 8ml; Girls: breast ≤ Tanner 3 weight SDS < 0 BMI SDS < 50 precentile for age and gender Signing inform consent forms Exclusion Criteria: Other indication for GH treatment. Bone age: boys>13.5, girls>11.5. Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems, metabolic disorders. Any known gastrointestinal problem including absorption problems. Any chronic treatment with medication that might affect appetite, weight or growth (for example steroids) except from Ritalin use Any eating disorders and/or psychiatric disorder

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moshe Phillip, Prof, MD

Phone

972-3-9253282

mosheph@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Alona Hamou, Msc

Phone

972-3-9253747

alonah@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, Prof, MD

Organizational Affiliation

Schneider Children's Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Schnider children's medical center

City

Petach-Tikva

ZIP/Postal Code

49202

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, Professor

Phone

972-3-9253778

mosheph@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Moshe Phillip, Prof

First Name & Middle Initial & Last Name & Degree

Revital Nimri, Dr.

First Name & Middle Initial & Last Name & Degree

Liat De Vries, Dr.

First Name & Middle Initial & Last Name & Degree

Liora Lazar, Dr.

First Name & Middle Initial & Last Name & Degree

Tal Oron, Dr.

First Name & Middle Initial & Last Name & Degree

Ariel Tenennbaum, Dr.

First Name & Middle Initial & Last Name & Degree

Shlomit Shalitin, Dr.

First Name & Middle Initial & Last Name & Degree

Judit Nir, Dr

First Name & Middle Initial & Last Name & Degree

Naama Fish, Dr

First Name & Middle Initial & Last Name & Degree

Sari Karpel, Dr

First Name & Middle Initial & Last Name & Degree

Sharon Demol, Dr

First Name & Middle Initial & Last Name & Degree

Marie Muller, Dr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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