Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-03 @ 4:11 PM
Study NCT ID:
NCT02742805
Status:
WITHDRAWN
Last Update Posted:
2018-05-01
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014581', 'term': 'Urticaria'}], 'ancestors': [{'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-04-14', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total Urticaria Severity Score (USS)', 'timeFrame': 'Change from Baseline to Month 6', 'description': 'The USS is a questionnaire which is used to measure urticaria severity. The questionnaire is comprised on 9 questions with each question having 7 total responses on a likert-type scale. Responses to each question range from 0 to 7.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects restarted on Omalizumab', 'timeFrame': '8 Months', 'description': 'Number of participants restarted on Omalizumab after coming off it at Month 4'}, {'measure': 'Change in total Urticaria Severity Score (USS)', 'timeFrame': 'Change from Baseline to Month 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hives'], 'conditions': ['Urticaria']}, 'descriptionModule': {'briefSummary': 'The proposed research is intended to determine if supplementation of relatively high dose vitamin D in chronic urticaria patients receiving omalizumab will result in continued symptomatic control of hives after the discontinuation of omalizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosed chronic urticaria\n* Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS \\<25\n\nExclusion Criteria:\n\n* Not capable of informed consent.\n* Not capable of answering the questionnaire.\n* Subjects with a pure physical urticaria.\n* Pregnant or lactating women.\n* Subjects with hypercalcemia (calcium \\> 10.3 mg/dl) or renal insufficiency (GFR \\<50 ml/min).\n* Subjects with prior anaphylaxis to omalizumab.\n* Currently taking high dose vitamin D supplementation.\n* Prior high dose vitamin D supplementation for urticaria with failure.\n* Baseline 25(OH)D \\>80 ng/ml\n* Subjects with sarcoidosis, hyperparathyroidism, histoplasmosis, lymphoma or tuberculosis'}, 'identificationModule': {'nctId': 'NCT02742805', 'briefTitle': 'Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation', 'orgStudyIdInfo': {'id': 'STUDY00002729'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose Vitamin D', 'description': 'Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.', 'interventionNames': ['Dietary Supplement: Vitamin D (4,000 IU/day)', 'Drug: Omalizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose Vitamin D', 'description': 'Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.', 'interventionNames': ['Dietary Supplement: Vitamin D (400 IU/day)', 'Drug: Omalizumab']}], 'interventions': [{'name': 'Vitamin D (4,000 IU/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High Dose of 4,000 IU/day.', 'armGroupLabels': ['High Dose Vitamin D']}, {'name': 'Vitamin D (400 IU/day)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Low Dose of 400 IU/day.', 'armGroupLabels': ['Low Dose Vitamin D']}, {'name': 'Omalizumab', 'type': 'DRUG', 'otherNames': ['Xolair'], 'description': 'Standard of care dose.', 'armGroupLabels': ['High Dose Vitamin D', 'Low Dose Vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Selina Gierer, D.O.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selina Gierer, D.O.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Selina Gierer, D.O.', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}