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

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.

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

Principal Investigator

Selina Gierer, D.O.

Study Contact

Caitlin McMillian, cmcmillian@kumc.edu, 913-588-0681

Estimated Completion Date

Sunday, December 1, 2019

ClinicalTrials.gov #

NCT02742805
04/18/2016