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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02742805

Enrollment

Registered

2016-04-19

Start date

2016-02-29

Completion date

2019-12-31

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urticaria

Keywords

hives

Brief 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.

Interventions

DIETARY_SUPPLEMENTVitamin D (4,000 IU/day)

High Dose of 4,000 IU/day.

DIETARY_SUPPLEMENTVitamin D (400 IU/day)

Low Dose of 400 IU/day.

DRUGOmalizumab

Standard of care dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in total Urticaria Severity Score (USS)	Change from Baseline to Month 6	The USS is a questionnaire which is used to measure urticaria severity. The questionnaire is comprised on 9 questions with each question having 7 total responses on a likert-type scale. Responses to each question range from 0 to 7.

Secondary

Measure	Time frame	Description
Number of subjects restarted on Omalizumab	8 Months	Number of participants restarted on Omalizumab after coming off it at Month 4
Change in total Urticaria Severity Score (USS)	Change from Baseline to Month 8	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026