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
NCT ID: NCT03053687
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
2017-11-01
2024-10-31
Brief Summary
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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.
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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 mineral
Placebo
Low caloric formula (Powder added to water) without added vitamins and mineral
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 mineral
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
14 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, MD
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Center
Locations
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Schnider 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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rmc082116ctil
Identifier Type: -
Identifier Source: org_study_id
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