Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00279812
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2006-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Selenium and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'charlotte.armah@ifr.ac.uk', 'phone': '01603 255 000', 'title': 'Dr Charlotte Armah', 'phoneExt': '5360', 'organization': 'Institute of Food Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'cold symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cellular and Humoral Immune Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions'}, {'id': 'OG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks'}, {'id': 'OG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks'}, {'id': 'OG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks'}, {'id': 'OG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks'}, {'id': 'OG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.34', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '0.29', 'spread': '0.09', 'groupId': 'OG003'}, {'value': '0.35', 'spread': '0.15', 'groupId': 'OG004'}, {'value': '0.35', 'spread': '0.13', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Total glutathione peroxidase 1 activity in platelets after supplementation', 'unitOfMeasure': 'umol/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject'}, {'type': 'SECONDARY', 'title': 'Selenium Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions'}, {'id': 'OG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks'}, {'id': 'OG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks'}, {'id': 'OG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks'}, {'id': 'OG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks'}, {'id': 'OG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '93.7', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '118.3', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '152.0', 'spread': '24.3', 'groupId': 'OG002'}, {'value': '177.4', 'spread': '26.3', 'groupId': 'OG003'}, {'value': '94.2', 'spread': '15.0', 'groupId': 'OG004'}, {'value': '106.0', 'spread': '11.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Plasma selenium concentration after supplementation', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject'}, {'type': 'SECONDARY', 'title': 'Selenoproteins and Se-biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions'}, {'id': 'OG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks'}, {'id': 'OG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks'}, {'id': 'OG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks'}, {'id': 'OG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks'}, {'id': 'OG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.96', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '6.73', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '6.59', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '4.80', 'spread': '1.03', 'groupId': 'OG004'}, {'value': '5.72', 'spread': '0.75', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Plasma selenoprotein P after the supllementation', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from 117 subjects because of incomplete time-course experiment for one subject and baseline plasma selenium concentration for one subject'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions'}, {'id': 'FG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks'}, {'id': 'FG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks'}, {'id': 'FG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks'}, {'id': 'FG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks'}, {'id': 'FG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment ran from May until the following February in 2005, 2006, and 2007. Study completed in June 2008. 272 volunteers completed a screening questionnaire,182 volunteers had blood samples screened, total of 133 were recruited and 119 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo\n\nSelenomethionine (supplement) and selenium enriched onions'}, {'id': 'BG001', 'title': '50ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks'}, {'id': 'BG002', 'title': '100ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks'}, {'id': 'BG003', 'title': '200ug Selenium Enriched Yeast', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks'}, {'id': 'BG004', 'title': 'Control Onion', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks'}, {'id': 'BG005', 'title': 'Enriched Onion', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '56.1', 'spread': '3.9', 'groupId': 'BG003'}, {'value': '58.2', 'spread': '5.1', 'groupId': 'BG004'}, {'value': '57.7', 'spread': '4.2', 'groupId': 'BG005'}, {'value': '57.12', 'spread': '1.12', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '65', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '3', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '25.9', 'spread': '3.8', 'groupId': 'BG003'}, {'value': '26.6', 'spread': '4.1', 'groupId': 'BG004'}, {'value': '26.1', 'spread': '2.4', 'groupId': 'BG005'}, {'value': '26', 'spread': '0.54', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2006-01-19', 'resultsFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2006-01-19', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-28', 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular and Humoral Immune Response', 'timeFrame': '12 weeks', 'description': 'Total glutathione peroxidase 1 activity in platelets after supplementation'}], 'secondaryOutcomes': [{'measure': 'Selenium Status', 'timeFrame': '10 weeks', 'description': 'Plasma selenium concentration after supplementation'}, {'measure': 'Selenoproteins and Se-biomarkers', 'timeFrame': '10 weeks', 'description': 'Plasma selenoprotein P after the supllementation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immune response', 'Selenomethionine', 'Selenium enriched foods', 'Selenium status', 'Selenium biomarkers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '26803169', 'type': 'DERIVED', 'citation': 'Ivory K, Prieto E, Spinks C, Armah CN, Goldson AJ, Dainty JR, Nicoletti C. Selenium supplementation has beneficial and detrimental effects on immunity to influenza vaccine in older adults. Clin Nutr. 2017 Apr;36(2):407-415. doi: 10.1016/j.clnu.2015.12.003. Epub 2015 Dec 24.'}, {'pmid': '21445287', 'type': 'DERIVED', 'citation': 'Goldson AJ, Fairweather-Tait SJ, Armah CN, Bao Y, Broadley MR, Dainty JR, Furniss C, Hart DJ, Teucher B, Hurst R. Effects of selenium supplementation on selenoprotein gene expression and response to influenza vaccine challenge: a randomised controlled trial. PLoS One. 2011 Mar 21;6(3):e14771. doi: 10.1371/journal.pone.0014771.'}, {'pmid': '20181815', 'type': 'DERIVED', 'citation': 'Hurst R, Armah CN, Dainty JR, Hart DJ, Teucher B, Goldson AJ, Broadley MR, Motley AK, Fairweather-Tait SJ. Establishing optimal selenium status: results of a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2010 Apr;91(4):923-31. doi: 10.3945/ajcn.2009.28169. Epub 2010 Feb 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the relationship between dose and form of selenium on immune function, and to identify functional markers of selenium status.', 'detailedDescription': 'One of the proposed consequences of marginal selenium status is impaired immune function. Establishing the potential role of selenium as an enhancer of immune response in vivo may provide evidence-base for public health policy, with important consequences for preventing influenza and similar diseases in the elderly.\n\nThe project consists of a placebo controlled selenium supplementation study and a dietary intervention with un-enriched and selenium enriched onions. In a parallel group design, subjects will be given either one of three doses of Selenomethionine (50, 100 or 200µg selenium/day) or a placebo per day or selenium enriched or un-enriched onions (in the form of test meals) for 12 weeks. Changes in the expression of Se-responsive genes and proteins in blood will be measured and compared with changes in plasma Se concentration and selected selenoproteins. The relationship between dietary Se intake and systemic and mucosal immune responses to influenza vaccine will be examined. Changes in immune cell populations and the influence of Se on NK and CD8 cytotoxicity will be determined by flow cytometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age 50-64\n* Plasma selenium level \\<1.2µmol/l (±10%)\n\nExclusion Criteria:\n\n* Elevated blood pressure measurements (\\<90/50 or \\<95/50 if symptomatic or \\>160/100)\n* Body mass index (BMI) \\<18.5 or \\>35\n* Results of the clinical screening which are judged by the Human Nutrition Unit (HNU) Medical advisor to be indicative of a health problem and could compromise the well-being of the volunteer if they participated, or which would affect the data.\n* Smokers\n* Diagnosed with gastrointestinal disease (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated) for which they have been taking prescription drugs on a chronic basis.\n* Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease.\n* On regularly prescribed medication known to have a profound effect on the immune function\n* Regularly using antacids and laxatives (at least once a week)\n* Sufferers of hay-fever taking regular steroid medication\n* Unwillingness to discontinue dietary (other than vitamins and minerals) or herbal supplements less than one month prior to the start of the study and for the duration of the study\n* Blood donation within 16 weeks of the first study sample and who intend to donate blood less than 16 weeks after the last study sample\n* Antibiotic use within four weeks prior to starting the study\n* Those who receive or plan to receive any other type of immunisation during the study period\n* Those who have received an immunisation within 6 months of the start of the study\n* Intention to go on holiday/trips for more than 2 weeks during the twelve week intervention\n* Those planning a holiday/trip that requires immunisation during the twelve week intervention period\n* Parallel participation in another research project which involves dietary intervention or sampling of biological fluids/materials\n* Allergic to eggs or egg products\n* Allergic to chicken protein\n* Allergic to the antibiotic Gentamicin\n* A history of Guillain-Barre syndrome'}, 'identificationModule': {'nctId': 'NCT00279812', 'briefTitle': 'Selenium and Immune Function', 'organization': {'class': 'OTHER', 'fullName': 'Quadram Institute Bioscience'}, 'officialTitle': 'Selenium and Immune Function', 'orgStudyIdInfo': {'id': 'IFR02/2005'}, 'secondaryIdInfos': [{'id': 'FSA 51949F', 'type': 'OTHER', 'domain': 'Food Standards Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '50ug selenium enriched yeast', 'description': '50ug/d selenium enriched yeast (containing 60% selenomethionine)', 'interventionNames': ['Dietary Supplement: 50ug selenium enriched yeast']}, {'type': 'EXPERIMENTAL', 'label': '100ug selenium enriched yeast', 'description': '100ug/d selenium enriched yeast (containing 60% selenomethionine)', 'interventionNames': ['Dietary Supplement: 100ug selenium enriched yeast']}, {'type': 'EXPERIMENTAL', 'label': '200ug selenium enriched yeast', 'description': '200ug/d selenium enriched yeast (containing 60% selenomethionine)', 'interventionNames': ['Dietary Supplement: 200ug selenium enriched yeast']}, {'type': 'EXPERIMENTAL', 'label': 'Control onion', 'description': '3 meals/wk containing un-enriched onions equivalent to 4ug/d Se', 'interventionNames': ['Dietary Supplement: Control onion']}, {'type': 'EXPERIMENTAL', 'label': 'Enriched onion', 'description': '3 meals/wk containing enriched onions equivalent to 50ug/d Se', 'interventionNames': ['Dietary Supplement: Enriched onion']}], 'interventions': [{'name': '50ug selenium enriched yeast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Selenomethionine supplement (50ug/d Se) for 12 weeks', 'armGroupLabels': ['50ug selenium enriched yeast']}, {'name': '100ug selenium enriched yeast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Selenomethionine supplement (100ug/d Se) for 12 weeks', 'armGroupLabels': ['100ug selenium enriched yeast']}, {'name': '200ug selenium enriched yeast', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Selenomethionine supplement (200ug/d Se) for 12 weeks', 'armGroupLabels': ['200ug selenium enriched yeast']}, {'name': 'Control onion', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 meals per week containing un-enriched onion (4ug/d) for 12 weeks', 'armGroupLabels': ['Control onion']}, {'name': 'Enriched onion', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 meals per week containing un-enriched onion (50ug/d) for 12 weeks', 'armGroupLabels': ['Enriched onion']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo supplement for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NR4 7UA', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Institute of Food Research', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Susan J Fairweather-Tait, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of East Anglia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quadram Institute Bioscience', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food Standards Agency, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}