Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-27 @ 4:13 AM
Study NCT ID:
NCT03132103
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementation and Immunity/Physical Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-02-13', 'releaseDate': '2020-02-03'}, {'releaseDate': '2025-02-14', 'unreleaseDate': '2025-02-14'}], 'estimatedResultsFirstSubmitDate': '2020-02-03'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-24', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D status', 'timeFrame': 'Up to 20 months', 'description': 'Circulating 25-hydroxy-vitamin D, 1,25-d OH(OH)D'}], 'secondaryOutcomes': [{'measure': 'Physical performance 1', 'timeFrame': 'Up to 20 months', 'description': 'Vertical Jump height (cm) and peak power output (watts)'}, {'measure': 'Physical performance 2', 'timeFrame': 'Up to 20 months', 'description': 'Maximal dynamic lift strength (kg)'}, {'measure': 'Physical performance 3', 'timeFrame': 'Up to 20 months', 'description': 'Multi-stage fitness test predicted VO2max (mL/kg/min)'}, {'measure': 'Hepatitis B antibody', 'timeFrame': 'Up to 20 months', 'description': 'Antibody produced in response to the presence of Hepatitis B antigen (e.g. Hepatitis B vaccine)'}, {'measure': 'Mucosal immunity', 'timeFrame': 'Up to 20 months', 'description': 'Secretory Immunoglobulin A levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D deficiency', 'Simulated sunlight radiation', 'Oral vitamin D3'], 'conditions': ['Vitamin D Status']}, '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of vitamin D supplementation on vitamin D status, immunity and physical performance.', 'detailedDescription': 'Vitamin D plays a key role in bone mineralisation and has been linked to immune defence maintenance and muscle function. Vitamin D is primarily obtained from endogenous synthesis in response to skin sunlight exposure and follows a seasonal pattern; whereby, vitamin D levels peak at the end of the summer and fall to a trough during winter. If winter vitamin D levels can be increased to match those found in summer using supplementation, it is proposed sufficient vitamin D levels will improve physical performance and reduce susceptibility to illness in military recruits.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Passed medical assessment by medical doctor\n\nExclusion Criteria:\n\n* Medically deferred by medical doctor\n* Regular sun bed use\n* Holiday in a hot sunny climate in \\<3 months\n* Regular vitamin D supplementation'}, 'identificationModule': {'nctId': 'NCT03132103', 'briefTitle': 'Vitamin D Supplementation and Immunity/Physical Performance', 'organization': {'class': 'OTHER', 'fullName': 'Bangor University'}, 'officialTitle': 'The Effect of Vitamin D Supplementation on Vitamin D Status, Immunity and Physical Performance', 'orgStudyIdInfo': {'id': '692/Gen/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solar simulated radiation (SSR)', 'description': 'Solar simulated radiation (SSR)', 'interventionNames': ['Radiation: Solar simulated radiation (SSR)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo SSR', 'description': 'Placebo SSR', 'interventionNames': ['Radiation: Placebo SSR']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Vitamin D3', 'description': 'Oral Vitamin D3', 'interventionNames': ['Dietary Supplement: Oral Vitamin D3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Oral Vitamin D3', 'description': 'Placebo Oral Vitamin D3', 'interventionNames': ['Dietary Supplement: Placebo Oral Vitamin D3']}], 'interventions': [{'name': 'Oral Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oral Vitamin D3']}, {'name': 'Placebo Oral Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo Oral Vitamin D3']}, {'name': 'Solar simulated radiation (SSR)', 'type': 'RADIATION', 'armGroupLabels': ['Solar simulated radiation (SSR)']}, {'name': 'Placebo SSR', 'type': 'RADIATION', 'armGroupLabels': ['Placebo SSR']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DL9 3PS', 'city': 'Catterick', 'state': 'North Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Neil P Walsh, PhD', 'role': 'CONTACT', 'email': 'n.walsh@bangor.ac.uk', 'phone': '01248', 'phoneExt': '3480'}, {'name': 'Julie P Greeves, PhD', 'role': 'CONTACT', 'email': 'ARTD-OccMed-SSO@mod.uk', 'phone': '94344', 'phoneExt': '8193'}, {'name': 'Julie P Greeves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Infantry Training Centre', 'geoPoint': {'lat': 54.37542, 'lon': -1.63328}}], 'centralContacts': [{'name': 'Prof Neil Walsh, PhD', 'role': 'CONTACT', 'email': 'n.walsh@bangor.ac.uk', 'phone': '01248', 'phoneExt': '383480'}, {'name': 'Dr Julie Greeves, PhD', 'role': 'CONTACT', 'email': 'ArmyMed-SHA-APRC-ResDir@mod.uk', 'phone': '01264', 'phoneExt': '886827'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangor University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of East Anglia', 'class': 'OTHER'}, {'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-03', 'type': 'RELEASE'}, {'date': '2020-02-13', 'type': 'RESET'}, {'date': '2025-02-14', 'type': 'RELEASE'}, {'date': '2025-02-14', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Bangor University'}}}}