Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
NCT ID: NCT02742805
Last Updated: 2018-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-02-29
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High Dose Vitamin D
Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
Vitamin D (4,000 IU/day)
High Dose of 4,000 IU/day.
Omalizumab
Standard of care dose.
Low Dose Vitamin D
Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
Vitamin D (400 IU/day)
Low Dose of 400 IU/day.
Omalizumab
Standard of care dose.
Interventions
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Vitamin D (4,000 IU/day)
High Dose of 4,000 IU/day.
Vitamin D (400 IU/day)
Low Dose of 400 IU/day.
Omalizumab
Standard of care dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS \<25
Exclusion Criteria
* Not capable of answering the questionnaire.
* Subjects with a pure physical urticaria.
* Pregnant or lactating women.
* Subjects with hypercalcemia (calcium \> 10.3 mg/dl) or renal insufficiency (GFR \<50 ml/min).
* Subjects with prior anaphylaxis to omalizumab.
* Currently taking high dose vitamin D supplementation.
* Prior high dose vitamin D supplementation for urticaria with failure.
* Baseline 25(OH)D \>80 ng/ml
* Subjects with sarcoidosis, hyperparathyroidism, histoplasmosis, lymphoma or tuberculosis
18 Years
ALL
No
Sponsors
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Selina Gierer, D.O.
OTHER
Responsible Party
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Selina Gierer, D.O.
Assistant Professor
Principal Investigators
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Selina Gierer, D.O.
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY00002729
Identifier Type: -
Identifier Source: org_study_id
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