Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-03 @ 6:18 AM
Study NCT ID:
NCT02197702
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2014-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D in Preschoolers With Viral-induced Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Francine.m.ducharme@umontreal.ca', 'phone': '5143454931', 'title': 'Dr Francine Ducharme', 'phoneExt': '4398', 'organization': 'StJustineH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 17, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 19, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'General (SOC)', 'notes': 'Includes:\n\nFEVER, FATIGUE, PAIN IN BOTH LEGS, PAIN LEFT HAND, TOOTHACHE, SLEEP DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'infections and infestations (SOC)', 'notes': 'Includes: OTITIS, PNEUMONIA, PHARYNGITIS, GASTROENTERITIS, STREPTOCOCCUS PHARYNGITIS, SINUSITIS, CONJONCTIVITIS etc.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 49, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 39, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Respiratory (SOC)', 'notes': 'Includes:\n\nBRONCHITIS/BRONCHIOLITIS, COUGH, ADENOID HYPERTROPHY, CHRONIC RHINITIS, SNEEZING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Blood and lymphatic system disorders (SOC)', 'notes': 'Includes:\n\nHETEROZYGOTIE AC, ANEMIA, EPISTAXIS, SPLENOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Ear and labyrinth disorders (SOC)', 'notes': 'Includes:\n\nOtalgia , Ruptured tympanic membrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Eye disorders (SOC)', 'notes': 'Strabism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Gastrointestinal disorders (SOC)', 'notes': 'Includes:\n\nVOMITING, CONSTIPATION, DIARRHEA, RECTAL PROLAPSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Immune system disorders (SOC)', 'notes': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Investigations (SOC)', 'notes': 'Includes:\n\nELEVATED CA:CR RATIO, INCREASE BLOOD PHOSPHORUS, LOW ALP, INCREASE IN BLOOD CALCIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Investigations', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Musculoskeletal disorders (SOC)', 'notes': 'PULLED ELBOW', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Nervous system disorder (SOC)', 'notes': 'Includes: SEIZURE, PERVASIVE DEVELOPMENT DISORDERS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Reproductive system (SOC)', 'notes': 'PHIMOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Skin and subcutaneous tissue disorders (SOC)', 'notes': 'Includes: RASH/ERYTHEMA, ECZEMA, GIANOTTI CROSTI SYNDROME, LÉSIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'System Organ Class'}, {'term': 'Surgical and medical procedures (SOC)', 'notes': 'Includes: FACE TRAUMA TEETH EXTRACTION, MYRINGOTOMY AND TUBE PLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'System Organ Class'}], 'seriousEvents': [{'term': 'peribronchitis', 'notes': 'requin hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Serum 25OHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '-6.6', 'upperLimit': '15.1'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '19.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the adjusted change from baseline 25OHD over 7 months', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Total 25OHD ≥75 Nmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'title': 'at 3.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'at 7 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at 3.5 and 7 months', 'description': 'Group difference in the number of participants with total 25OHD ≥75 nmol/L', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers of participants analyzed in Placebo and Vitamin D groups were 23 and 19 at 3.5 months time point, and 22 and 18 at 7 months time point.'}, {'type': 'SECONDARY', 'title': 'Emergency Department Visit for an Asthma Flare-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '1.49'}, {'value': '1.04', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '1.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the number of emergency department visits for asthma per child', 'unitOfMeasure': 'visits/child', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The numbers of participants analyzed were 24 in Placebo and 23 in Vitamine D groups.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hypercalciuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Group difference in the number of participants with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25mmol/mmol for children aged 1-2yrs or greater than 1mmol/mmol for those aged 2-5yrs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Elevated Serum 25-hydroxyvitamin D (25OHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Number of Participants with ≥1 occurrence of elevated serum 25OHD (greater than 225 nmol/L)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perturbation of the Calcium Homeostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Number of participants with ≥1 occurrence of a clinically significant perturbation of the calcium homeostasis (serum Ca, Ph, Alkaline phosphatase), defined as outside normal laboratory values', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of URTIs (Verbal Report)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'groupId': 'OG000', 'lowerLimit': '3.37', 'upperLimit': '5.03'}, {'value': '4.48', 'groupId': 'OG001', 'lowerLimit': '3.66', 'upperLimit': '5.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Adjusted Incidence proportion of URTIs (the event rate per child occurring during the 7-month follow up period)', 'unitOfMeasure': 'number of URTI/child', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Viral Upper Respiratory Tract Infections (URTI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '4.24', 'groupId': 'OG000', 'lowerLimit': '3.32', 'upperLimit': '5.42'}, {'value': '3.63', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '4.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the number of reported viral upper respiratory tract infections reported in the ADYC diary.', 'unitOfMeasure': 'Viral URTI/child', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rescue β2-agonist Use During an Asthma Flare-up (Standardized Over 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '50.2'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '49.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': "Group difference in the cumulative daily use of rescue β2-agonist use, standardized over 1 week, as documented by parents on the 'Asthma Flare-up Diary for Young CHildren' (ADYCs) during a URTI or an asthma exacerbation. A cumulative number of inhalations documented in ADYC were divided by the number of days of asthma exacerbation and multiplied by 7 days. Albuterol doses received during acute care visits and hospital admissions were not considered.", 'unitOfMeasure': 'cumulative number of puffs standardized', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Severity of Asthma Symptoms During an Asthma Flare-up (Cumulative Daily Score Standardized Over 7 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '15.1'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '13.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the severity on the asthma symptoms documented as the sum of daily score on the 'Asthma FLare-up DIary for Young Children' questionnaire where best =1, worst = 7 on each day during asthma flare-up. Since the flare-up typically lasts several days, the cumulative daily score, standarized over 7 days (total possible scale range: 7-49), may increase due to severity or due to the duration of the event. Lower scores indicate lowest severity, higher score indicate longer or higher severity of symptoms.", 'unitOfMeasure': 'score on a ADYC scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Asthma Symptoms During a Flare-up (by Diary)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '6.2'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the duration of asthma symptoms documented on the 'Asthma FLare-up DIary for Young Children' questionnaire", 'unitOfMeasure': 'days/exacerbation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Asthma Exacerbations/Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '1.24'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.63', 'upperLimit': '1.45'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the 7-month follow-up period', 'description': 'The number of asthma exacerbations requiring rescue oral corticosteroids per child', 'unitOfMeasure': 'Courses of oral steroids/child', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Impact of Exacerbations on Caregivers' Functional Status", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.8'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '3.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the caregivers' functional status measured on the 'Effect of a child's asthma flare-up on parents' (ECAP) questionnaire (best =7, worst = 1)", 'unitOfMeasure': 'Score of a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Caregivers' Workday Lost (in Days Per Flare-up)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '2.5'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Mean group difference in the caregivers' number of workdays lost per exacerbation, reported in number of days per flare-up", 'unitOfMeasure': 'days per flare-up', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent of Participants With at Least 1 Exacerbation Requiring Rescue Oral Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 7-month follow-up period', 'description': 'The percentage of participants with ≥1 reported asthma exacerbations requiring rescue oral corticosteroids', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Asthma Symptoms During a Flare-up (Verbal Report)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.\n\nplacebo: Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'OG001', 'title': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.\n\nvitamin D: Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '9.0'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': 'Group difference in the duration of asthma symptoms by verbal report.', 'unitOfMeasure': 'days/exacerbation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'FG001', 'title': 'Vitamin D', 'description': 'Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrew at Visit 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew at Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrew at Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Analysed for Main Outcome', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter'}, {'id': 'BG001', 'title': 'Vitamin D', 'description': 'Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '2.9', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '2.9', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Caucasian', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Vitamin D intake IU/day -Median (25%, 75%)', 'classes': [{'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000', 'lowerLimit': '162', 'upperLimit': '270'}, {'value': '182', 'groupId': 'BG001', 'lowerLimit': '125', 'upperLimit': '425'}, {'value': '215', 'groupId': 'BG002', 'lowerLimit': '165', 'upperLimit': '356'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Serum vitamin D <75 nmol/L - n (%)', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'identical placebo'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2014-07-18', 'resultsFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hypercalciuria', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Group difference in the number of participants with ≥1 occurrence of hypercalciuria (urinary calcium: creatinine greater than 1.25mmol/mmol for children aged 1-2yrs or greater than 1mmol/mmol for those aged 2-5yrs)'}, {'measure': 'Elevated Serum 25-hydroxyvitamin D (25OHD)', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Number of Participants with ≥1 occurrence of elevated serum 25OHD (greater than 225 nmol/L)'}, {'measure': 'Perturbation of the Calcium Homeostasis', 'timeFrame': 'At any point during the 7-month follow-up period', 'description': 'Number of participants with ≥1 occurrence of a clinically significant perturbation of the calcium homeostasis (serum Ca, Ph, Alkaline phosphatase), defined as outside normal laboratory values'}, {'measure': 'Number of URTIs (Verbal Report)', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Adjusted Incidence proportion of URTIs (the event rate per child occurring during the 7-month follow up period)'}, {'measure': 'Viral Upper Respiratory Tract Infections (URTI)', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the number of reported viral upper respiratory tract infections reported in the ADYC diary.'}, {'measure': 'Rescue β2-agonist Use During an Asthma Flare-up (Standardized Over 7 Days)', 'timeFrame': 'During the 7-month follow-up period', 'description': "Group difference in the cumulative daily use of rescue β2-agonist use, standardized over 1 week, as documented by parents on the 'Asthma Flare-up Diary for Young CHildren' (ADYCs) during a URTI or an asthma exacerbation. A cumulative number of inhalations documented in ADYC were divided by the number of days of asthma exacerbation and multiplied by 7 days. Albuterol doses received during acute care visits and hospital admissions were not considered."}, {'measure': 'Severity of Asthma Symptoms During an Asthma Flare-up (Cumulative Daily Score Standardized Over 7 Days)', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the severity on the asthma symptoms documented as the sum of daily score on the 'Asthma FLare-up DIary for Young Children' questionnaire where best =1, worst = 7 on each day during asthma flare-up. Since the flare-up typically lasts several days, the cumulative daily score, standarized over 7 days (total possible scale range: 7-49), may increase due to severity or due to the duration of the event. Lower scores indicate lowest severity, higher score indicate longer or higher severity of symptoms."}, {'measure': 'Duration of Asthma Symptoms During a Flare-up (by Diary)', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the duration of asthma symptoms documented on the 'Asthma FLare-up DIary for Young Children' questionnaire"}, {'measure': 'Number of Asthma Exacerbations/Child', 'timeFrame': 'During the 7-month follow-up period', 'description': 'The number of asthma exacerbations requiring rescue oral corticosteroids per child'}, {'measure': "Impact of Exacerbations on Caregivers' Functional Status", 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Group difference in the caregivers' functional status measured on the 'Effect of a child's asthma flare-up on parents' (ECAP) questionnaire (best =7, worst = 1)"}, {'measure': "Caregivers' Workday Lost (in Days Per Flare-up)", 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': "Mean group difference in the caregivers' number of workdays lost per exacerbation, reported in number of days per flare-up"}, {'measure': 'Percent of Participants With at Least 1 Exacerbation Requiring Rescue Oral Corticosteroids', 'timeFrame': 'During the 7-month follow-up period', 'description': 'The percentage of participants with ≥1 reported asthma exacerbations requiring rescue oral corticosteroids'}, {'measure': 'Duration of Asthma Symptoms During a Flare-up (Verbal Report)', 'timeFrame': 'During an URTI or flare-up during the 7-month follow-up period', 'description': 'Group difference in the duration of asthma symptoms by verbal report.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Serum 25OHD', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the adjusted change from baseline 25OHD over 7 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Total 25OHD ≥75 Nmol/L', 'timeFrame': 'at 3.5 and 7 months', 'description': 'Group difference in the number of participants with total 25OHD ≥75 nmol/L'}, {'measure': 'Emergency Department Visit for an Asthma Flare-up', 'timeFrame': 'During the 7-month follow-up period', 'description': 'Group difference in the number of emergency department visits for asthma per child'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RCT', 'asthma', 'pediatric', 'virus', 'corticosteroid'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '30777118', 'type': 'RESULT', 'citation': 'Ducharme FM, Jensen M, Mailhot G, Alos N, White J, Rousseau E, Tse SM, Khamessan A, Vinet B. Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial. Trials. 2019 Feb 18;20(1):138. doi: 10.1186/s13063-019-3184-z.'}, {'pmid': '33305842', 'type': 'DERIVED', 'citation': 'Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.'}], 'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/30777118/', 'label': 'article'}]}, 'descriptionModule': {'briefSummary': 'In this 7-month randomized controlled trial, children aged 1-6 years with asthma attacks triggered mostly by colds, will receive a high dose of vitamin D or a placebo every 3.5 months during their usual clinic visit. This study will test whether children receiving a high dose of vitamin D have less frequent and less severe asthma exacerbations compared with those receiving placebo.The study will also document the safety profile of this strategy.', 'detailedDescription': "IMPORTANT NOTE: Due to receiving a 2-year partial funding enabling only a single-centre pilot trial, rather than an adequately-powered multicentre study, the primary outcome was modified post hoc for the overall change from baseline in total serum 25OHD during the study as well as at 3.5 and 7 months, similar to our previous pilot study.(NCT01999907) Post hoc secondary outcomes included the group difference in the proportion of children with total 25OHD ≥75 nmol/L at 3.5 and 7 months and in the rate of oral corticosteroid courses per child. Other a priory specified outcomes included the proportion of children with hypercalciuria (Ca:Cr) \\>1.25 (1-2 years), \\>1 (2-5 years) nmol/nmol at any point in time; proportion of children with ≥1 exacerbation requiring rescue oral steroids (former primary outcome); number of emergency department (ED) visits; intensity and duration of asthma symptoms and cumulative use of rescue ß2-agonist use, documented on Asthma Flare-up Diary for Young Children (ADYC); the impact of parents' functional status during exacerbations ascertained on the Effect of a child's asthma flare-up on parents; and duration of URTI.\n\nBased on this analysis of this new post-hoc primary outcome, we have changed the intervention and the primary outcome and obtained funding for a new large multicentre study NCT03365687. it is thus important to share the results of this current trial with other investigators\n\nPRIOR REPORTED DESCRIPTION Design: A multicenter triple-blind randomized parallel-group, placebo-controlled trial of vitamin D3 supplementation. Children aged 1-5 years with (i) physician-diagnosed asthma, predominantly triggered by upper respiratory tract infections (URTIs), (ii) ≥4 reported URTIs in the past year, and (iii) ≥1 exacerbation requiring OCS (a recognised marker of moderate and severe exacerbations) in the past 6 months or ≥2 in the past 12 months, will be randomly allocated to one of two treatments in blocks of 4-6, stratified on recruitment site: Intervention group (n=432)-100,000 IU oral vitamin D3; control group (n=432)-identical placebo, for 2 oral doses, 3.5 months apart. Co-intervention with asthma therapy (preventive or pre-emptive ICS) will be left to the discretion of the physician and documented. Children will be followed every 3.5 months as per usual practice, with a home visit 10 days after each bolus, during which urine and blood will be sampled for urinary calcium:creatinine ratio, serum vitamin D, markers of calcium metabolism, and mechanistic exploration. A validated diary will serve to document the intensity and severity of exacerbations. In two sites, preschool lung function will be documented (if ≥ 3yrs). Outcomes: Primary endpoint-number of exacerbations requiring rescue oral corticosteroids (OCS) per child, documented by medical and pharmacy records. Secondary outcomes: duration and severity of exacerbations (symptoms \\& β2-agonist use, by diary; emergency visits, by medical records), parental functional status (by validated instrument), asthma therapy intensification and health care and direct costs (by health records \\& parent reports). Safety, mechanistic, exploratory outcomes: hypercalciuria, calcium metabolism, excess vitamin D, change in serum gene expression at 10 days (first 25 patients); and change from baseline at 7 months in preschool lung function (2 sites). Based on 3 published RCTs, a sample of 432 per arm (400+7.5% attrition) will provide 80% power (2-tailed alpha of 5%) to detect a 25% reduction in number of exacerbations requiring OCS/child (0.55 vs. 0.4125)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1-5 years\n* physician-diagnosed asthma as per the Global Initiative for Asthma (GINA) guidelines\n* URTIs as the main asthma trigger (parental report)\n* ≥4 URTIs in the past 12 months (parental report)\n* ≥1 asthma exacerbation requiring rescue oral corticosteroids (OCS) in the past 6 months or ≥2 in the past 12 months\n\nExclusion Criteria:\n\n* intake or intention to use more than 400 IU/day of vitamin D supplement\n* extreme prematurity (\\<28 weeks gestation)\n* infants \\<12 months of age\n* no vitamin D supplementation when breast-fed\n* recent (\\<1 year) immigrants from a region at high risk of rickets\n* children with vitamin D restrictive diets e.g. vegans\n* other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)\n* condition(s) that alter calcium or vitamin D metabolism/absorption (hypo/hyperparathyroidism, kidney/liver disease, inflammatory bowel disease)\n* medications that interfere with vitamin D metabolism (anti-epileptics, diuretics, antacids, anti-fungal drug)\n* vitamin D supplementation \\>1000 IU/ day in last 3 months\n* anticipated difficult follow-up (unable to attend clinic visits; plan to leave the province).'}, 'identificationModule': {'nctId': 'NCT02197702', 'acronym': 'DIVA', 'briefTitle': 'Vitamin D in Preschoolers With Viral-induced Asthma', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Vitamin D In the Prevention of Viral-induced Asthma of Preschoolers: a Randomised Controlled Trial (RCT)- (DIVA)', 'orgStudyIdInfo': {'id': 'DIVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 ml identical placebo taken by mouth at baseline and 3.5 months.', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'Vitamin D (100,000IU) given in a 2 ml oral dose at baseline and 3.5months.', 'interventionNames': ['Dietary Supplement: vitamin D']}], 'interventions': [{'name': 'vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['cholecalciferol'], 'description': 'Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter', 'armGroupLabels': ['Vitamin D']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Francine M Ducharme, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Justine's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, {'name': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke', 'class': 'OTHER'}, {'name': "Montreal Children's Hospital of the MUHC", 'class': 'OTHER'}, {'name': "British Columbia Children's Hospital", 'class': 'OTHER'}, {'name': 'London Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Professor Francine Ducharme', 'investigatorAffiliation': "St. Justine's Hospital"}}}}