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

Withdrawn before enrolling · Phase 4

Conditions studied: Urticaria

In brief

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.

Key facts

Study ID

NCT02742805

Run by

Selina Gierer, D.O.

People needed

0

Starts

2016-02-01

Expected to finish

2019-12-01

Last updated by the study team

2018-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Physician diagnosed chronic urticaria
• Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS <25

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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