Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

Study Overview
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Brief Summary
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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.

Official Title
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Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

Conditions
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Urticaria

Intervention / Treatment
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* Dietary Supplement: Vitamin D (4,000 IU/day)
* Dietary Supplement: Vitamin D (400 IU/day)
* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosed chronic urticaria 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 informed consent. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Vitamin D<br>Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab. | Dietary Supplement: Vitamin D (4,000 IU/day)<br>* High Dose of 4,000 IU/day.<br>Drug: Omalizumab<br>* Standard of care dose.<br>* Other names: Xolair;|
| Active Comparator: Low Dose Vitamin D<br>Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab. | Dietary Supplement: Vitamin D (400 IU/day)<br>* Low Dose of 400 IU/day.<br>Drug: Omalizumab<br>* Standard of care dose.<br>* Other names: Xolair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total Urticaria Severity Score (USS) | 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. | Change from Baseline to Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects restarted on Omalizumab | Number of participants restarted on Omalizumab after coming off it at Month 4 | 8 Months | 
| Change in total Urticaria Severity Score (USS) |  | Change from Baseline to Month 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hives