Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-30 @ 3:27 AM
Study NCT ID:
NCT02416895
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Status and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-02-26', 'releaseDate': '2025-02-05'}], 'estimatedResultsFirstSubmitDate': '2025-02-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D 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': 'Blood serum collected at Week 1 (start of training) and Week 13 (end of training).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 264}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D measured by liquid chromatography tandem mass spectroscopy', 'timeFrame': 'Up to 20 months', 'description': 'Circulating 25-hydroxy-vitamin D'}], 'secondaryOutcomes': [{'measure': 'Immune function measured by analytic biochemistry assay', 'timeFrame': 'Up to 20 months', 'description': 'In vivo immune measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '32390123', 'type': 'DERIVED', 'citation': 'Kashi DS, Oliver SJ, Wentz LM, Roberts R, Carswell AT, Tang JCY, Jackson S, Izard RM, Allan D, Rhodes LE, Fraser WD, Greeves JP, Walsh NP. Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D3 and simulated sunlight supplementation trial in healthy adults. Eur J Nutr. 2021 Feb;60(1):475-491. doi: 10.1007/s00394-020-02261-w. Epub 2020 May 10.'}, {'pmid': '31061425', 'type': 'DERIVED', 'citation': 'Tang JCY, Jackson S, Walsh NP, Greeves J, Fraser WD; Bioanalytical Facility team. The dynamic relationships between the active and catabolic vitamin D metabolites, their ratios, and associations with PTH. Sci Rep. 2019 May 6;9(1):6974. doi: 10.1038/s41598-019-43462-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the relationship between Vitamin D status and immunity.', 'detailedDescription': 'Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young adults who are starting basic training in the army.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Passed medical assessment by medical doctor\n* Passed audio test (this is part of medical assessment)\n* Met physical fitness requirements\n\nExclusion Criteria:\n\n• Medically deferred by medical doctor'}, 'identificationModule': {'nctId': 'NCT02416895', 'briefTitle': 'Vitamin D Status and Immune Function', 'organization': {'class': 'OTHER', 'fullName': 'Bangor University'}, 'officialTitle': 'Vitamin D Status and in Vivo Immune Function', 'orgStudyIdInfo': {'id': '165/Gen/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Army recruits', 'description': 'Army recruits at the start of basic training will complete an in vivo immunity model', 'interventionNames': ['Other: In vivo immunity model']}], 'interventions': [{'name': 'In vivo immunity model', 'type': 'OTHER', 'description': 'A measure of in vivo immune function.', 'armGroupLabels': ['Army recruits']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DL9 3PS', 'city': 'Catterick', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Infantry Training Centre', 'geoPoint': {'lat': 54.37542, 'lon': -1.63328}}], 'overallOfficials': [{'name': 'Julie Greeves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HQ Army Research and Training Division'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangor University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of East Anglia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-05', 'type': 'RELEASE'}, {'date': '2025-02-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bangor University'}}}}