Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 11:08 AM
Study NCT ID:
NCT01921894
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2013-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D and Severe Asthma Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'juan.celedon@chp.edu', 'phone': '412-692-8429', 'title': 'Dr. Juan C. Celedon, Niels K. Jerne Professor of Pediatrics', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome includes any report of adverse events.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome includes any report of adverse events.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 200 IU per day were analyzed. Outcome includes any report of adverse events.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.'}, {'id': 'OG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.'}, {'id': 'OG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In this pilot study, we wanted to report and compare the proportion of subjects who achieved vitamin D sufficiency after 8 weeks of treatment with one of three vitamin D doses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vitamin D Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (\\>10.8 mg/dl) or elevated uCa/uCr (\\>0.37).'}, {'id': 'OG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (\\>10.8 mg/dl) or elevated uCa/uCr (\\>0.37).'}, {'id': 'OG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (\\>10.8 mg/dl) or elevated uCa/uCr (\\>0.37).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Participants with vitamin D toxicity, hypercalcemia (\\>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (\\>0.37)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We wanted to report and compare the proportion of subjects who had vitamin D toxicity, hypercalcemia or an elevated UCa/UCr ratio across the three treatment arms'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Elevated Urinary Calcium/Creatinine Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio \\> 0.37'}, {'id': 'OG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio \\> 0.37'}, {'id': 'OG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio \\> 0.37'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 and/or 8 weeks', 'description': 'Elevated urinary calcium/creatinine ratio defined as UCa/UCr \\> 0.37 after either 4 weeks or 8 weeks of supplementation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We wanted to compare the proportion of subjects who had an elevated UCa/UCr ratio across the three groups in this pilot Phase I Study'}, {'type': 'SECONDARY', 'title': 'Number of Participants With FEV1 < 80% of Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome was defined having FEV1 \\< 80% of predicted'}, {'id': 'OG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined having FEV1 \\< 80% of predicted'}, {'id': 'OG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 200 IU per day were analyzed. Outcome was defined having FEV1 \\< 80% of predicted'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': "Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We wanted to compare the proportion of subjects whose FEV1 % predicted fell below 80% predicted across the three arms in this pilot Phase I study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.'}, {'id': 'OG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.'}, {'id': 'OG002', 'title': 'Cholecalciferol 200 IU', 'description': 'All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The characteristics of the study population are the same as described for the other primary outcome (vitamin D sufficiency at 8 weeks)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks\n\nCholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.'}, {'id': 'FG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks\n\nCholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.'}, {'id': 'FG002', 'title': 'Cholecalciferol 200 IU', 'description': 'Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks\n\nCholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Subjects were enrolled from: 1) the Emergency Department of Children's Hospital of Pittsburgh (CHP), 2) the Pulmonary Medicine and Allergy clinics of CHP, 3) the General Pediatric Clinics of CHP, and 4) participants in a prior study of the Pediatric Environmental Medicine Center of CHP (who had consented to be contacted about studies of asthma).", 'preAssignmentDetails': 'We recruited 48 children who met initial inclusion/exclusion criteria. Of these 48 children, 20 were excluded because of a 25(OH)D ≥30 ng/ml (n=13) or lack of bronchodilator response or airway responsiveness (n=7) at visit 1. Of the 28 remaining children, 4 were excluded because of non-adherence or poor asthma control during the run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cholecalciferol 4000 IU', 'description': 'Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks'}, {'id': 'BG001', 'title': 'Cholecalciferol 2000 IU', 'description': 'Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks'}, {'id': 'BG002', 'title': 'Cholecalciferol 200 IU', 'description': 'Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic white', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Non-Hispanic Black', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic/Others', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2013-08-09', 'resultsFirstSubmitDate': '2016-02-15', 'studyFirstSubmitQcDate': '2013-08-09', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-02', 'studyFirstPostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation', 'timeFrame': '8 weeks', 'description': 'The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation'}, {'measure': 'Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation', 'timeFrame': '4 weeks', 'description': 'The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Vitamin D Toxicity', 'timeFrame': '8 weeks', 'description': 'Participants with vitamin D toxicity, hypercalcemia (\\>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (\\>0.37)'}, {'measure': 'Number of Participants With Elevated Urinary Calcium/Creatinine Ratio', 'timeFrame': '4 and/or 8 weeks', 'description': 'Elevated urinary calcium/creatinine ratio defined as UCa/UCr \\> 0.37 after either 4 weeks or 8 weeks of supplementation'}, {'measure': 'Number of Participants With FEV1 < 80% of Predicted', 'timeFrame': '8 weeks', 'description': "Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'vitamin D'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study of vitamin D is designed to assess both the safety and efficacy of potential doses (2,000 IU/day and 4,000 IU/day) in raising a vitamin D level to a normal range in a short period of time (e.g. 4 weeks or less) compared to 200 IU/day.\n\nIn children with vitamin D insufficiency or deficiency who are at risk for severe asthma exacerbations, we hypothesize that both vitamin D supplementation with 4,000 IU/day and 2,000 IU/day will safely achieve normal vitamin D levels, but that the higher dose (4,000 IU/day) will result in a larger proportion of subjects achieving this level at 4 and 8 weeks.', 'detailedDescription': 'Asthma is a major public health problem in the United States and worldwide. Severe disease exacerbations account for the majority of costs attributable to asthma in the United States. Vitamin D is an essential nutrient with significant immuno-modulatory effects. The observation that vitamin D insufficiency and asthma share risk factors such as urban residence, obesity, and African American ethnicity has generated significant interest in exploring a link between these two conditions.\n\nThis is an 8-week randomized, double-masked, controlled trial of vitamin D3 (2,000 IU/day and 4,000 IU/day) to achieve vitamin D sufficiency (a serum 25(OH)D ≥30 ng/ml in 60 school-aged children (ages 6 to 14 years) who have vitamin D insufficiency (a serum 25(OH)D \\<30 ng/ml) and are at risk for severe asthma exacerbations, but whose asthma that is well-controlled on medium-dose inhaled corticosteroid (ICS) at the end of a 4-week run-in period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 6 years of age and younger than 15 years of age\n* Have physician-diagnosed asthma\n* Taking a medium dose of ICS (e.g. fluticasone 220mcg BID) for daily asthma control for at least 6 months in the prior year.\n* Have had a severe asthma exacerbation in the previous year, defined as an Emergency Department (ED) visit, hospitalization, or unscheduled clinic visit for asthma resulting in intramuscular, intravenous, or oral steroids.\n* Have bronchodilator responsiveness (BDR, an increase in FEV1 ≥12% from baseline after administration of inhaled albuterol) or (if no BDR) increased airway responsiveness to methacholine challenge\n* Have vitamin D insufficiency (a serum vitamin D (25(OH)D) level \\<30 ng/ml)\n* Have his/her parents give voluntary written consent to participate in the study\n\nExclusion Criteria:\n\n* Chronic respiratory disorder other than asthma (e.g., bronchiectasis).\n* Severe asthma, as evidenced by any of the following: a) chronic need for medication other than single controller therapy and inhaled β2-agonist, b) intubation for asthma at any time, and c) ≥2 hospitalizations or ≥6 severe asthma exacerbations in the previous year\n* History of cigarette smoking in the prior year or former smoking if ≥5 pack-years\n* Hepatic or renal disease, metabolic rickets, malabsorptive disorders, or other chronic diseases that would affect vitamin D metabolism\n* Immune deficiency, cleft palate or Down's syndrome, which might increase the child's likelihood of respiratory infections\n* Treatment with anticonvulsants or pharmacological doses of vitamin D (≥1,000 IU/day of vitamin D2 or D3)\n* Chronic oral corticosteroid therapy\n* Inability to perform acceptable spirometry\n* Use of investigational therapies or participation in clinical trials 30 days before or during the duration of the study\n* Serum calcium \\>10.8 mg/dl\n* Serum 25(OH) D \\<10 ng/ml (severe vitamin D deficiency)"}, 'identificationModule': {'nctId': 'NCT01921894', 'acronym': 'SAVED-P', 'briefTitle': 'Vitamin D and Severe Asthma Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Phase I Trial for Children With Vitamin D Insufficiency and High Risk of Severe Asthma Exacerbations', 'orgStudyIdInfo': {'id': 'SAVED-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol 4000 IU', 'description': 'Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Cholecalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'Cholecalciferol 2000 IU', 'description': 'Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Cholecalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cholecalciferol 200 IU', 'description': 'Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks', 'interventionNames': ['Dietary Supplement: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vitamin D3'], 'description': 'vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.', 'armGroupLabels': ['Cholecalciferol 200 IU', 'Cholecalciferol 2000 IU', 'Cholecalciferol 4000 IU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Juan C Celedon, M.D., Dr.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Juan Celedon, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}