Back to resultsSustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Primary Purpose
Urticaria
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin D (4,000 IU/day)
Vitamin D (400 IU/day)
Omalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Urticaria focused on measuring hives
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose Vitamin D
Low Dose Vitamin D
Arm Description
Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of subjects restarted on Omalizumab
Number of participants restarted on Omalizumab after coming off it at Month 4
Change in total Urticaria Severity Score (USS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02742805
Brief Title
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Official Title
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Selina Gierer, D.O.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urticaria
Keywords
hives
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Vitamin D
Arm Type
Experimental
Arm Description
Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
Arm Title
Low Dose Vitamin D
Arm Type
Active Comparator
Arm Description
Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (4,000 IU/day)
Intervention Description
High Dose of 4,000 IU/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D (400 IU/day)
Intervention Description
Low Dose of 400 IU/day.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
Standard of care dose.
Primary Outcome Measure Information:
Title
Change in total Urticaria Severity Score (USS)
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.
Time Frame
Change from Baseline to Month 6
Secondary Outcome Measure Information:
Title
Number of subjects restarted on Omalizumab
Description
Number of participants restarted on Omalizumab after coming off it at Month 4
Time Frame
8 Months
Title
Change in total Urticaria Severity Score (USS)
Time Frame
Change from Baseline to Month 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selina Gierer, D.O.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
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