Clinical trial NCT04962360: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ISS- Idiopathic Short Stature
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: height standard deviation score (SDS)
timeFrame: at 6 moths
measure: weight standard deviation score
timeFrame: at 6 months
Secondary outcomes:
measure: BMI SDS
timeFrame: at 6 months
measure: Lean body mass
timeFrame: at 6 months
measure: muscle mass
timeFrame: at 6 months
measure: Fat mass
timeFrame: at 6 months
measure: Fat mass percentage
timeFrame: at 6 months
Other outcomes:
measure: height SDS
timeFrame: at 12 months
measure: Weight SDS
timeFrame: at 12 months
measure: BMI SDS
timeFrame: at 12 months
measure: Lean body mass
timeFrame: at 12 months
measure: muscle mass
timeFrame: at 12 months
measure: fat mass
timeFrame: at 12 months
measure: fat mass percentage
timeFrame: at 12 months
Locations:
city: Petah tikva
country: Israel
facility: Schneider children's medical center
Study officials:
affiliation: Schnieder Children's Medical Center
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References: