Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:52 PM
Study NCT ID:
NCT00139451
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutrients and Hormones: Effects in Boys With Disordered Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011628', 'term': 'Puberty, Delayed'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D004392', 'term': 'Dwarfism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-11', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in height, weight, and body composition', 'timeFrame': '6month, 12month, 18month'}], 'secondaryOutcomes': [{'measure': 'Changes in total energy expenditure', 'timeFrame': '6month, 12month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GH', 'Delayed Growth', 'Energy Expenditure', 'Puberty', 'Nutrition', 'Short Stature'], 'conditions': ['Constitutional Growth Delay', 'Nutrition Disorders', 'Growth Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://kidshealth.org', 'label': 'issues related to child health'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.', 'detailedDescription': 'Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys 7-10 years old who are very short and below average in weight but otherwise healthy.\n* Delay in skeletal maturation \\> 1 year.\n\nExclusion Criteria:\n\n* Growth hormone deficiency\n* Chronic illness\n* Participation in high endurance athletics'}, 'identificationModule': {'nctId': 'NCT00139451', 'briefTitle': 'Nutrients and Hormones: Effects in Boys With Disordered Growth', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Nutrients and Hormones: Effects in Boys With Disordered Growth', 'orgStudyIdInfo': {'id': 'IRB # 04-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition and Growth Hormone', 'interventionNames': ['Drug: Pediasure', 'Drug: GH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Observation and Growth Hormone', 'interventionNames': ['Drug: GH']}], 'interventions': [{'name': 'Pediasure', 'type': 'DRUG', 'description': 'With the assistance of a research dietician, we will prescribe and monitor the use of a liquid food supplement (Pediasure). Adjustments to the supplementation will be made based on weight measurements in the clinic with subjects wearing paper gowns at 2 and 4w, and monthly thereafter, and repeat dietary intake and TEE assessment at 6 and 12mo.', 'armGroupLabels': ['Nutrition and Growth Hormone']}, {'name': 'GH', 'type': 'DRUG', 'description': 'Growth Hormone will be 0.3mg/kg/week, given SC once daily.', 'armGroupLabels': ['Nutrition and Growth Hormone', 'Observation and Growth Hormone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Nelly Mauras, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Clinic"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Endocrinology, Diabetes & Metabolism', 'investigatorFullName': 'Nelly Mauras', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}