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

April 30, 2018 updated by: Selina Gierer, D.O.
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Dose Vitamin D
Participants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab.
Dietary supplement: Vitamin D (4,000 IU/day)
High Dose of 4,000 IU/day.
Drug: Omalizumab
Standard of care dose.
Other Names:
  • Xolair
Active Comparator: Low Dose Vitamin D
Participants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab.
Drug: Omalizumab
Standard of care dose.
Other Names:
  • Xolair
Dietary supplement: Vitamin D (400 IU/day)
Low Dose of 400 IU/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total Urticaria Severity Score (USS)
Time Frame: 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.
Change from Baseline to Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selina Gierer, D.O.

Investigators

  • Principal Investigator: Selina Gierer, D.O., University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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