Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-29 @ 8:41 AM
Study NCT ID:
NCT01337635
Status:
TERMINATED
Last Update Posted:
2018-12-05
First Post:
2010-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vitamin D Deficiency and Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ychiu@mcw.edu', 'phone': '414-955-2818', 'title': 'Yvonne Chiu, MD', 'organization': 'Medical College of Wisconsin'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Dose Vitamin D', 'description': 'Treatment with cholecalciferol 400 IU daily at home.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose Vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Atopic Dermatitis Severity at the Completion of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dose Vitamin D', 'description': 'Treatment with cholecalciferol 400 IU daily at home.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}, {'id': 'OG001', 'title': 'High Dose Vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '43.4'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '30.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Restart Topical Steroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Dose Vitamin D', 'description': 'Treatment with cholecalciferol 400 IU daily at home.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}, {'id': 'OG001', 'title': 'High Dose Vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No subjects restarted topical steroids during the study period.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'No subjects restarted topical steroids during the study period.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'The time to restart topical steroids.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Dose Vitamin D', 'description': 'Treatment with cholecalciferol 400 IU daily at home.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}, {'id': 'FG001', 'title': 'High Dose Vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.\n\nVitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Dose Vitamin D', 'description': 'Treatment with cholecalciferol 400 IU oral daily at home for 6 weeks'}, {'id': 'BG001', 'title': 'High Dose Vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '10'}, {'value': '6.7', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '15'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Not meeting enrollment goals.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2010-11-03', 'resultsFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-06', 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atopic Dermatitis Severity at the Completion of Treatment', 'timeFrame': '6 weeks', 'description': 'SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Time to Restart Topical Steroids', 'timeFrame': '6 weeks', 'description': 'The time to restart topical steroids.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serum 25-hydroxyvitamin D level \\<20 ng/ml (\\<50 nmol/L)\n* Diagnosed with atopic dermatitis by a CHW pediatric dermatologist\n* Age 1-18 years old\n* Primary residence in Milwaukee County\n* Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis \\[SCORAD\\] score greater than 15)\n* On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)'}, 'identificationModule': {'nctId': 'NCT01337635', 'briefTitle': 'Vitamin D Deficiency and Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity', 'orgStudyIdInfo': {'id': 'CHW 10/146, GC 1169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose vitamin D', 'description': 'Treatment with cholecalciferol 400 IU daily at home.', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose vitamin D', 'description': 'Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'description': 'Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks', 'armGroupLabels': ['High dose vitamin D', 'Standard dose vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Yvonne Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital and Health System Foundation, Wisconsin"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital and Health System Foundation, Wisconsin", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yvonne Chiu', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}