Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 11:22 AM
Study NCT ID:
NCT01658267
Status:
COMPLETED
Last Update Posted:
2015-01-21
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compliance With Dietary Recommendations in Children at Risk for Undernutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-19', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with recommendation of a nutritional supplement consumption', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Children', 'Under-nutrition']}, 'descriptionModule': {'briefSummary': 'This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.', 'detailedDescription': 'This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (\\>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '36 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child is between 36 and 48 months of age.\n* Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.\n* Child is capable of oral feeding.\n* Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.\n\nExclusion Criteria:\n\n* Child whose either parent has BMI greater than or equal to 27.5 kg/m2.\n* Child allergic or intolerant to any ingredient found in the study product.\n* Child who was delivered pre-term.\n* Child was born small for gestational\n* Child had birth weight \\< 2500 g or \\> 4000 g.\n* Child has current acute or chronic infections.\n* Child demonstrates presence of severe gastrointestinal disorders.\n* Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.\n* Child has a diagnosis of hormonal or metabolic disorders.\n* Child has a congenital disease or genetic disorder.\n* Child is diagnosed with infantile anorexia nervosa.\n* Child has a developmental disability or physical disorder.\n* Child has disorders of hemoglobin structure, function or synthesis.\n* Child is participating in another study that has not been approved as a concomitant study."}, 'identificationModule': {'nctId': 'NCT01658267', 'briefTitle': 'Compliance With Dietary Recommendations in Children at Risk for Undernutrition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition', 'orgStudyIdInfo': {'id': 'AK86'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Supplement', 'description': "Instructions and techniques to improve the quality of the diet to meet the child's daily nutritional requirements will be provided.", 'interventionNames': ['Other: nutritional supplement']}], 'interventions': [{'name': 'nutritional supplement', 'type': 'OTHER', 'otherNames': ['Pediasure S229'], 'description': '2 servings per day', 'armGroupLabels': ['Nutritional Supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manila', 'country': 'Philippines', 'facility': 'Asian Hospital and Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'The Medical City', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'overallOfficials': [{'name': 'Dieu Huynh, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}