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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Vitamin D | Experimental | Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab. |
|
| Low Dose Vitamin D | Active Comparator | Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (4,000 IU/day) | Dietary Supplement | High Dose of 4,000 IU/day. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Selina Gierer, D.O. | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Vitamin D (400 IU/day) |
| Dietary Supplement |
Low Dose of 400 IU/day. |
|
| Omalizumab | Drug | Standard of care dose. |
|
|
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000888 |
| Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |