Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 4:29 PM
Study NCT ID:
NCT05437068
Status:
WITHDRAWN
Last Update Posted:
2023-03-01
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Supplementation in Children at Risk of Undernutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in research focus', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2022-06-15', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Parental Evaluation of Child's Healthy Growth", 'timeFrame': 'Baseline to 30 days and 120 days', 'description': "Parent-reported satisfaction and assessment of child's healthy growth on 10-point visual analog scale, scored from 0 Very dissatisfied/Strongly disagree to 10 Very satisfied/Strongly agree, with higher scores being favorable"}, {'measure': "Parental Assessment of Child's Sleep", 'timeFrame': 'Baseline to 30 days and 120 days', 'description': "Parent-reported questionnaire of child's usual amount of sleep (hours and minutes), and number (number of times) and length (minutes) of awakenings per night"}, {'measure': 'Adverse Event', 'timeFrame': 'Baseline to 120 days', 'description': 'Number of participants with reported adverse events'}, {'measure': 'Illness Questionnaire', 'timeFrame': 'Baseline to 120 days', 'description': 'Parent reported number of sick episodes, sick days, healthcare visits and symptoms, with higher number reported being less favorable'}, {'measure': 'Mid Upper Arm Muscle Circumference (MUAMC) Calculation', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Changes in MUAMC calculations'}, {'measure': 'Arm Muscle Area (AMA) Calculation', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Changes in AMA calculations'}, {'measure': 'Arm Fat Area (AFA) Calculation', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Changes in AFA calculations'}, {'measure': 'Arm Fat Index (AFI) Calculation', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Changes in AFI calculations'}], 'primaryOutcomes': [{'measure': 'Height-for-age-Z-score', 'timeFrame': 'Baseline to 120 days', 'description': 'Change in Height-for-age-Z-score'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Measured in Kg'}, {'measure': 'Height', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Measured in cm'}, {'measure': 'Mid-Upper-Arm Circumference (MUAC)', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Measured in cm'}, {'measure': 'Weight-for-Height Measurement Calculations', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Weight-for-height standard z scores and percentiles'}, {'measure': 'Weight-for-Age Measurement Calculations', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Weight-for-age standard z scores and percentiles'}, {'measure': 'BMI-for-Age Measurement Calculations', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'BMI-for-age standard z scores and percentiles'}, {'measure': 'Height-for-Age Measurement Calculations', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Height-for-age standard z scores and percentiles'}, {'measure': 'MUAC-for-Age Measurement Calculations', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'MUAC-for-age standard z scores and percentiles'}, {'measure': 'Dietary Intake', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Measured by 24-hour dietary recall'}, {'measure': 'Appetite', 'timeFrame': 'Baseline to 30 days and 120 days', 'description': 'Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable'}, {'measure': 'Physical Activity', 'timeFrame': 'Baseline to 30 days and120 days', 'description': 'Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition, Child']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nChild is between 1 year 0 days to 5 years 364 days old at enrolment\n\nUndernourished or at risk of undernutrition, defined as:\n\n* WHZ \\<- 1 and HAZ \\<-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or\n* BMIAZ \\<-1 and HAZ \\<-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards\n\nChild is not currently breastfed\n\nChild's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period\n\nChild is a singleton\n\nChild's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study\n\nChild's parent(s)/LG is not planning to relocate during the study period\n\nChild's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study\n\nExclusion Criteria:\n\nChild participates in another study that has not been approved as a concomitant study\n\nChild is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product\n\nChild had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG\n\nChild had birth weight \\< 2500 g or \\> 4000 g\n\nChild whose either parent has BMI ≥ 27.5 kg/m2\n\nChild has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis\n\nChild has been diagnosed with the following:\n\n* Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis\n* Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia\n* Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay\n* Disorders of hemoglobin structure, function or synthesis\n\nClinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product)\n\nAny other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study"}, 'identificationModule': {'nctId': 'NCT05437068', 'briefTitle': 'Nutritional Supplementation in Children at Risk of Undernutrition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition', 'orgStudyIdInfo': {'id': 'AL55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Nutritional Supplement (ONS) Group', 'description': 'Two servings per day in addition to dietary counseling', 'interventionNames': ['Other: Oral Nutritional Supplement (ONS)']}], 'interventions': [{'name': 'Oral Nutritional Supplement (ONS)', 'type': 'OTHER', 'description': 'ONS plus dietary counseling', 'armGroupLabels': ['Oral Nutritional Supplement (ONS) Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yen Ling Mandy Ow, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}