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

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Selina Gierer, D.O.
• Treatments: Ergocalciferols; Omalizumab; Vitamin D; Vitamins

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