Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04368520
Status:
WITHDRAWN
Last Update Posted:
2024-07-05
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two treatment arms of vitamin D3: low dose (800IU) vs. high dose (3,200IU) given daily, for 3 months'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'COVID-19 pandemic prevented start-up', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rhinovirus titres', 'timeFrame': '+3 to +5 days after inoculation', 'description': 'PCR-detected rhinovirus-16 load sampled from the nasal mucosa'}], 'secondaryOutcomes': [{'measure': 'Respiratory symptom score (Jackson Score)', 'timeFrame': '+1 to +14 days after inoculation', 'description': 'Total self-reported respiratory symptom score (scored 0-32; increasing score equals increasing symptom severity)'}, {'measure': 'Cytokine and chemokine concentrations', 'timeFrame': 'Day 0 and +4 days after inoculation', 'description': 'Change in concentrations of inflammatory mediators (Including, but not limited to IL-1β, IL-2, IL-4, IL-5, Il-6, IL- 7, IL-8 \\[CXCL8\\], IL-10, IL-12, IL-13, IL-15, IL-17, IL-1RA, IL-2R, IFN-α, IFN-γ, TNF-α, MCP-1 \\[CCL2\\], MIP- 1α \\[CCL3\\], MIP-1β \\[CCL4\\], RANTES \\[CCL5\\], eotaxin \\[CCL11\\], MIG \\[CXCL9\\], IP-10 \\[CXCL10\\], EGF, FGF-basic, HGF, VEGF, G-CSF, GM-CSF)'}, {'measure': 'Change in level of vitamin D-regulated gene expression', 'timeFrame': 'Day 0 and +4 days after inoculation', 'description': 'Change in expression of DHCR7, CYP2R1, CYP3A4, CYP27A1, CYP27B1, CYP24A1, VDR, DBP, RXRA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhinovirus'], 'conditions': ['Common Cold']}, 'descriptionModule': {'briefSummary': 'A phase II randomised, placebo-controlled trial to identify the optimal regimen of vitamin D supplementation for rhinovirus protection, determined by host responses to a clinically induced rhinovirus challenge. The primary outcome is rhinovirus titre after inoculation with rhinovirus; secondary outcomes are self-reported respiratory symptom scores, concentrations of cytokines and chemokines sampled from the nasal mucosa, and the transcriptional responses of nasal epithelial cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70 years\n2. Gives written informed consent\n3. Serum 25-hydroxyvitamin D concentration \\<75 nmol/L\n4. Agrees not to take supplement containing vitamin D during participation\n5. Agrees not to commence smoking or vaping during participation\n\nExclusion criteria:\n\n1. Current smoker or vaper\n2. Taken vitamin D supplement or other supplement containing vitamin D, in previous 3 months\n3. Sunny holiday abroadI, defined as any location 51 degrees North/South of the equator, for ≥1 week, in the previous 3 months\n4. Dependent(s) \\<6 months old\n5. Positive serology for anti-RV16 antibodies\n6. Living with someone with severe airways disease\n7. Any of the following medical conditions:\n\n 1. Diabetes mellitus\n 2. Asthma\n 3. Chronic Obstructive Pulmonary Disease\n 4. Respiratory allergies\n 5. Sarcoidosis\n 6. Hyperparathyroidism\n 7. Nephrolithiasis\n 8. Active tuberculosis\n 9. Liver failure\n 10. Renal failure\n 11. Lymphoma or other malignancy not in remission for ≥ 3 years'}, 'identificationModule': {'nctId': 'NCT04368520', 'briefTitle': 'Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Clinical Trial to Optimise Levels of Vitamin D for Rhinovirus Protection (COLD)', 'orgStudyIdInfo': {'id': 'COLDstudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose vitamin D3', 'interventionNames': ['Dietary Supplement: Vitamin D3']}, {'type': 'EXPERIMENTAL', 'label': 'High dose vitamin D3', 'interventionNames': ['Dietary Supplement: Vitamin D3']}], 'interventions': [{'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months', 'armGroupLabels': ['Low dose vitamin D3']}, {'name': 'Vitamin D3', 'type': 'DIETARY_SUPPLEMENT', 'description': '3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months', 'armGroupLabels': ['High dose vitamin D3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Hypromellose capsules, given daily for 3 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': '2 years after completion of the trial', 'ipdSharing': 'YES', 'description': 'De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}