Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 1:01 PM
Study NCT ID:
NCT01559766
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014802', 'term': 'Vitamin A Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vitamin A', 'Dietary requirement', 'Dietary records', 'Deuterated retinol dilution technique', 'Chinese children', 'Dietary intake of vitamin A', 'Vitamin A liver reserves'], 'conditions': ['Vitamin A Deficiency']}, 'descriptionModule': {'briefSummary': 'Vitamin A deficiency remains a major public health problem in developing country worldwide. Young Children are considered to be at greatest risk of deficiency. However, there is little information on the vitamin A requirement of Chinese children. In the present study, about 400 children aged between 4 and 9 years old in a kindergarten and an elementary school of Shiyan City were screened before admission by questionnaire and anthropometric measurement. The vitamin A status of children was assessed by serum vitamin A level, relative dosage reaction and stable-isotope dilution technique. At the same time, their dietary vitamin A intakes were estimated by weighted-food dietary survey. The dietary vitamin A requirement in young children was determined on the basis of dietary vitamin A intakes in Children with adequate vitamin A level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study was carried out in a kindergarten and an elementary school in Shiyan city, Hubei province of China. Initially, 201 kindergarten children (4-6 years old) and 202 grade children (7-9 years old) were subjected to a questionnaire survey on personal information, medical history and dietary habits including dietary supplements.ongoing or previous illnesses, having taken nutritional supplements within 3 months, positive results in the fat absorption test or parasite test, increased level of CRP (\\> 8 mg/L), or lower serum level of retinol (\\<1.40 umol/L), and higher ratio in relative dosage reaction test(\\>20%) .After the screening, 123 children were selected and completed the study, but 60 subjects were randomly selected for the DRD test to evaluate liver vitamin A storage.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* well-nourished children with normal serum retinol(\\>=1.40umol/L)\n\nExclusion Criteria:\n\n* ongoing or previous illnesses,\n* having taken nutritional supplements within 3 months,\n* positive results in the fat absorption test or parasite test,\n* increased level of CRP (\\> 8 mg/L), or\n* lower serum level of retinol (\\< 1.40 umol/L)'}, 'identificationModule': {'nctId': 'NCT01559766', 'briefTitle': 'Dietary Vitamin A Requirement in Chinese Children and the New Technology of Dietary Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Estimating Dietary Vitamin A Requirement in Chinese Children by Stable-isotope Dilution Technique', 'orgStudyIdInfo': {'id': 'No.2008BAI58B03'}}, 'armsInterventionsModule': {'armGroups': [{'label': '4-6 years old group'}, {'label': '7-9 years old group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '442500', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Shiyan Centre for Disease Control and Prevention', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}], 'overallOfficials': [{'name': 'Xiufa Sun, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'ShiYan Centre for Disease Control and Prevention', 'class': 'UNKNOWN'}, {'name': 'Tufts Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiufa Sun', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}