Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 4:46 PM
Study NCT ID:
NCT01415557
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2011-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 227}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the micronutrient status in the study subjects at 6 months', 'timeFrame': '6 months', 'description': 'The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in cognitive performance at 6 months', 'timeFrame': '6 months', 'description': 'Change from baseline in cognitive test scores at the end of the intervention for all subjects.'}, {'measure': 'Change from baseline in the physical performance at 6 months', 'timeFrame': '6 months', 'description': 'Change from baseline in the physical test scores at end of intervention for all subjects'}, {'measure': 'Change from baseline in the fatigue score at 6 months', 'timeFrame': 'Baseline and Endline (six months)', 'description': 'Change from baseline in the fatigue score at end of intervention for all subjects'}, {'measure': 'Morbidity Assessment', 'timeFrame': '6 months', 'description': 'Morbidity will be recorded on a weekly basis from the start until the end of the intervention'}, {'measure': 'Prevalence of Micronutrient Deficiency', 'timeFrame': '6 months', 'description': 'Prevalence of micronutrient deficiency in each study arm at the end the intervention'}, {'measure': 'Change from baseline in anthropometric scores at 6 months', 'timeFrame': '6 months', 'description': 'Change from baseline in anthropometric measures (Standardized (WHO, 2007) weight for age, height for age and BMI for age of the study subjects) at the end of the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['micronutrient', 'healthy children', 'vitamins', 'minerals', 'cognition', 'physical performance', 'iron', 'Micronutrient status', 'Cognitive Performance'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25746819', 'type': 'DERIVED', 'citation': 'Kuriyan R, Thankachan P, Selvam S, Pauline M, Srinivasan K, Kamath-Jha S, Vinoy S, Misra S, Finnegan Y, Kurpad AV. The effects of regular consumption of a multiple micronutrient fortified milk beverage on the micronutrient status of school children and on their mental and physical performance. Clin Nutr. 2016 Feb;35(1):190-198. doi: 10.1016/j.clnu.2015.02.001. Epub 2015 Feb 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy school going children\n* not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb\\<8g/dl)\n* Age: 7-10 years\n* Not taking any food supplements/fortified drinks\n* Not planning to move out during the study duration\n\nExclusion Criteria:\n\n* Age: \\<7 and \\>10 years\n* Severe anemia (Hb \\< 8 g/dl)\n* Severely malnourished children with weight-for-height z-score \\<-3 will be excluded.\n* Cardiovascular disease on clinical examination or history\n* Underlying respiratory disease with impairment of lung function\n* Physical disability which can interfere or limit performance of tests\n* Recent history (3 months prior) of serious infections, injuries and/ or surgeries\n* Any food allergy or food intolerance\n* Participation in any nutritional study in the last 1year\n* Children consuming nutritional supplements and/ or health food drinks'}, 'identificationModule': {'nctId': 'NCT01415557', 'briefTitle': 'Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mondelēz International, Inc.'}, 'officialTitle': 'The Effects of Regular Consumption of a Multiple Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren and on Their Mental and Physical Performance', 'orgStudyIdInfo': {'id': 'KFTSJRI2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Fortified Control Product', 'description': 'Non-fortified control beverage', 'interventionNames': ['Other: Non-Fortified Control Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Micronutrient Fortified Test Product', 'description': 'Micronutrient fortified test beverage', 'interventionNames': ['Other: Micronutrient Fortified Test Product']}], 'interventions': [{'name': 'Non-Fortified Control Product', 'type': 'OTHER', 'description': 'Non-Fortified Control Beverage', 'armGroupLabels': ['Non-Fortified Control Product']}, {'name': 'Micronutrient Fortified Test Product', 'type': 'OTHER', 'description': 'Micronutrient Fortified Test Beverage', 'armGroupLabels': ['Micronutrient Fortified Test Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560034', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'St. Johns Research Institute', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Prashanth Thankachan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Research Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mondelēz International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "St. John's Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}