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

Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02742805
• Other study ID #: STUDY00002729
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urticaria

Intervention

Dietary Supplement:
• Vitamin D (4,000 IU/day)
High Dose of 4,000 IU/day.
• Vitamin D (400 IU/day)
Low Dose of 400 IU/day.

Drug:
• Omalizumab
Standard of care dose.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Selina Gierer, D.O.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of subjects restarted on Omalizumab	Number of participants restarted on Omalizumab after coming off it at Month 4	8 Months
Secondary	Change in total Urticaria Severity Score (USS)		Change from Baseline to Month 8