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

Phase 4

Withdrawn

• Conditions: Urticaria
• Interventions: Dietary Supplement: Vitamin D (400 IU/day); Dietary Supplement: Vitamin D (4,000 IU/day); Drug: Omalizumab

• Registration Number: NCT02742805
• Lead Sponsor: Selina Gierer, D.O.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Vitamin D	Vitamin D (400 IU/day)	Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
High Dose Vitamin D	Vitamin D (4,000 IU/day)	Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
Low Dose Vitamin D	Omalizumab	Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
High Dose Vitamin D	Omalizumab	Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.

Primary Outcome Measures

Name	Time	Method
Change in total Urticaria Severity Score (USS)	Change from Baseline to Month 6	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

Name	Time	Method
Number of subjects restarted on Omalizumab	8 Months	Number of participants restarted on Omalizumab after coming off it at Month 4
Change in total Urticaria Severity Score (USS)	Change from Baseline to Month 8

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States