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

Selina Gierer, D.O.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Urticaria

Interventions

Vitamin D (4,000 IU/day)DIETARY_SUPPLEMENT

High Dose of 4,000 IU/day.

Vitamin D (400 IU/day)DIETARY_SUPPLEMENT

Low Dose of 400 IU/day.

OmalizumabDRUG

Standard of care dose.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline to Month 6

Secondary Outcomes

Number of subjects restarted on Omalizumab

Number of participants restarted on Omalizumab after coming off it at Month 4

Time frame: 8 Months

Change in total Urticaria Severity Score (USS)

Time frame: Change from Baseline to Month 8

Data from ClinicalTrials.gov

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