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

Selina Gierer, D.O.

Status and phase: Withdrawn; Phase 4

Conditions: Urticaria

Treatments: Drug: Omalizumab; Dietary Supplement: Vitamin D (400 IU/day); Dietary Supplement: Vitamin D (4,000 IU/day)

Study type: Interventional

Funder types: Other

Identifiers

NCT02742805

STUDY00002729

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

High Dose Vitamin D

Experimental group

Description:

Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.

Treatment:

Dietary Supplement: Vitamin D (4,000 IU/day)

Drug: Omalizumab

Low Dose Vitamin D

Active Comparator group

Description:

Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.

Treatment:

Dietary Supplement: Vitamin D (400 IU/day)

Drug: Omalizumab