Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT02742805
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02742805
Study Brief:
Protocol Section:
NCT02742805