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 | Recruiting

• 1 other identifier: rmc26021ctil
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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 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.

Conditions

ISS- Idiopathic Short Stature

Outcome Measures

Primary Outcomes (2)

• height standard deviation score (SDS)

  at 6 moths

• weight standard deviation score

  at 6 months

Secondary Outcomes (5)

• BMI SDS

  at 6 months

• Lean body mass

  at 6 months

• muscle mass

  at 6 months

• Fat mass

  at 6 months

• Fat mass percentage

  at 6 months

Other Outcomes (7)

• height SDS

  at 12 months

• Weight SDS

  at 12 months

• BMI SDS

  at 12 months

Study Arms (2)

Nutritional standardized supplementation formula.

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Nutritional supplementation standardized formula DIETARY_SUPPLEMENT

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

Nutritional standardized supplementation formula.

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• SGA/ IUGR
• Diagnosis of GH deficiency
• 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.
• Any known gastrointestinal problem including absorption problems.
• Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids).
• Any eating disorders and/or psychiatric disorder
• Milk or other food allergies

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider children's medical center

Petah Tikva, Israel

RECRUITING

Study Officials

• Moshe Phillip, Prof

  Schnieder Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Phillip, Prof.

CONTACT

972-3-9253282; mosheph@clalit.org.il

Alonah Hamou, MSc

CONTACT

972-39253747; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 15, 2021
• Study Start: August 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)