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
NCT ID: NCT04962360
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2021-08-01
2025-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
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
Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Interventions
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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
Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
Eligibility Criteria
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Inclusion Criteria
2. Age 5-10 years inclusive.
3. Tanner stage 1 (gonadarche).
4. BMI \<85 percentile for age and gender.
Exclusion Criteria
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
5 Years
10 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Schnieder Children's Medical Center
Locations
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Schneider children's medical center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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rmc26021ctil
Identifier Type: -
Identifier Source: org_study_id
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