Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-05 @ 1:21 AM
Study NCT ID:
NCT01789866
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DHA & Lutein and fMRI Brain Mapping in Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'plasma lutein and Red blood cell DHA', 'timeFrame': '5 years 8 months to 6 years', 'description': 'plasma lutein and red blood cell DHA biochemistries'}], 'primaryOutcomes': [{'measure': 'fMRI data', 'timeFrame': '5 years 8 months to 6 years', 'description': 'fMRI data will be collected for subjects differentiated by DHA and lutein status completing tasks for working memory, working language, visual working memory and visual acuity'}], 'secondaryOutcomes': [{'measure': 'cognitive development with standardized developmental tests', 'timeFrame': '5 years 8 months to 6 years', 'description': 'Assessment with the Kaufman Developmental Assessment Battery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DHA', 'lutein', 'neurodevelopment', 'fMRI'], 'conditions': ['Healthy Nutrition']}, 'descriptionModule': {'briefSummary': "Studies suggest that lutein and n-3 fatty acids may influence the development of a child's brain and may be related to how well children learn. Both lutein and the n-3 fats (also known as omega-3 fats) are not made by the body and must be obtained in the diet. The investigators are interested to understand the importance of n-3 fats and lutein to child brain development. Functional magnetic resonance imaging (fMRI) will make it possible to look into the brain from the outside and see which parts of the brain are being used as children complete working memory tasks. The investigators will study brain function using fMRI among children with different intakes of n-3 fats and lutein.\n\nHypothesis:\n\n1. Children 6 years of age consuming \\< 25 mg/day DHA and \\< 400 μg lutein/day will show poorer activation of brain areas on fMRI than children consuming \\> 150 mg/day DHA and \\> 1,200 μg/day lutein.\n2. Children consuming \\< 400 μg lutein/day and \\> 150 mg/day DHA will also show differences in fMRI results when compared to children consuming \\> 150 mg/day DHA and \\> 1,200 μg/day lutein.", 'detailedDescription': "Study Design:\n\nA cross-sectional observational study of 62 school-age children in Vancouver, Canada.\n\nDietary intake assessment:\n\nChildren's dietary intake over the previous four weeks was estimated by interview with a parent using a Food Frequency Questionnaire. Three 24h recalls were administered, using the five-pass review technique. The children's dietary intake of DHA was quantified using nutrient analysis software (ESHA Food Processor SQL, version 10.10.0.0; ESHA Research), using Canadian foods, and checking the fatty acid composition of all foods and beverages for accuracy, modifying if necessary based on labels or laboratory analysis of the product.\n\nBlood Markers EDTA venous blood was collected and was centrifuged to collect Red Blood Cells (RBC). RBC fatty acids were extracted and quantified by routine gas liquid chromatography. RBC-DHA to DPA (n-6) ratio was used as an indicator of DHA status.\n\nCognitive Measures The Kaufman Assessment Battery for Children (KABC)-II (Kaufman, 2004) was administered by one of two individuals trained in child psychometric testing. The KABC consists of several scales: (1) the Sequential Processing Scale measures short-term memory; (2) the Learning Ability Scale measures long-term storage and retrieval; \\& (3) the Simultaneous Processing Scale measures visual processing. Results of these 3 scales may be combined to give a composite Mental Performance Index (MPI) score. The Delayed Recall subtest was used to evaluate long-term memory.\n\nStatistical Analysis DHA intake and RBC-DHA:DPA were log transformed; transformed data were used in the subsequent analyses. Pearson's correlation tests were conducted to test (1) the associations between DHA intake and RBC-DHA:DPA ratio and (2) the associations between DHA intake and RBC-DHA:DPA with KABC-II domain scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '78 Months', 'minimumAge': '69 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'school-age children differentiated by intake of DHA and lutein', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full-term\n* single birth (no multiple births)\n* no major illness or surgery requiring hospitalization likely to impact the outcomes\n* no metabolic, congenital or allergic disease that impact food intakes\n* parents have sufficient command of English language to complete the informed consent and study documents\n\nThe specific inclusion enrollment criteria for:\n\nGroup 1: children consuming \\<25 mg/day DHA and \\< 400 μg/day lutein, n=24; Group 2: children consuming \\>150 mg/day DHA and \\>1,200 μg/day lutein, n=24; Group 3: children consuming \\>150 mg/day DHA and \\<400 μg/day lutein, n=10;\n\nExclusion Criteria:\n\n* children of mothers enrolled in studies by our group that involved randomization to supplemental DHA during pregnancy\n* children for whom blood, diet records or developmental tests at 5 years and 9 months of age are incomplete\n* children consuming 25-150 mg/day DHA or 400-1200 μg/day lutein\n* children of mothers who do not sign the informed consent\n* any children having a cardiac pacemaker, aneurysm clip, cochlear implant of possible metallic foreign bodies in the eyes or other contraindication as detailed in the C\\&W MRI Patient Screening Form will be excluded from this study.'}, 'identificationModule': {'nctId': 'NCT01789866', 'briefTitle': 'DHA & Lutein and fMRI Brain Mapping in Healthy Children', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Dynamic Roles of Dietary Docosahexaenoic Acid (DHA) and Lutein in Brain Function in Healthy Children', 'orgStudyIdInfo': {'id': 'H12-01306'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Child & Family Resaerch Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Sheila M Innis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Child & Family Research Institute, University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Yvonne Lamers', 'investigatorAffiliation': 'University of British Columbia'}}}}