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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 10
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Schneider children's medical center
RECRUITING
Petah Tikva
Contact Information
Primary
Moshe Phillip, Prof.
mosheph@clalit.org.il
972-3-9253282
Backup
Alonah Hamou, MSc
alonah@clalit.org.il
972-39253747
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 64
Treatments
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.
Placebo_comparator: Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Sponsors
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov