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

NCT02742805 | Withdrawn Phase 4

• 1 other identifier: STUDY00002729
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urticaria

Keywords

hives

Outcome Measures

Primary Outcomes (1)

• Change in total Urticaria Severity Score (USS)

  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 Outcomes (2)

• Number of subjects restarted on Omalizumab

  8 Months

• Change in total Urticaria Severity Score (USS)

  Change from Baseline to Month 8

Study Arms (2)

High Dose Vitamin D

EXPERIMENTAL

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); Drug: Omalizumab

Low Dose Vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D (400 IU/day); Drug: Omalizumab

Interventions

Vitamin D (4,000 IU/day) DIETARY_SUPPLEMENT

High Dose of 4,000 IU/day.

High Dose Vitamin D

Vitamin D (400 IU/day) DIETARY_SUPPLEMENT

Low Dose of 400 IU/day.

Low Dose Vitamin D

Omalizumab DRUG

Standard of care dose.

Also known as: Xolair

High Dose Vitamin D; Low Dose Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosed chronic urticaria
• Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS \<25

You may not qualify if:

• 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

Sponsors & Collaborators

• Selina Gierer, D.O.: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Urticaria

Interventions

Vitamin D; Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Selina Gierer, D.O.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)