UrticariaPhase 4NCT02742805
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
A Phase 4 study testing Vitamin D (4,000 IU/day), Vitamin D (400 IU/day) and Omalizumab in people with Urticaria, run by Selina Gierer, D.O. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urticaria
- What is being tested?
- Vitamin D (4,000 IU/day), Vitamin D (400 IU/day) and Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosed chronic urticaria
- Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS <25
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
- Being tested
- Vitamin D (4,000 IU/day), Vitamin D (400 IU/day), Omalizumab
- Keywords
- hives
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (4,000 IU/day)Dietary supplement
High Dose of 4,000 IU/day.
Vitamin D (400 IU/day)Dietary supplement
Low Dose of 400 IU/day.
OmalizumabDrug
Also called Xolair
Standard of care dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Vitamin D (400 IU/day); Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Month 6
Secondary outcomes (2)
Number of subjects restarted on Omalizumab
Number of participants restarted on Omalizumab after coming off it at Month 4
Measured: 8 Months
Change in total Urticaria Severity Score (USS)
Measured: Change from Baseline to Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selina Gierer, D.O.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selina Gierer, D.O., University of Kansas Medical Center
- Investigators
- Selina Gierer, D.O., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742805
- Sponsor's protocol ID
- STUDY00002729
- Status last verified
- Apr 2018
- First submitted
- 14 Apr 2016
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation
- ClinicalTrials.gov ID
- NCT02742805
- Acronym / sponsor ID
- STUDY00002729
- Conditions
- Urticaria
- Keywords
- hives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Selina Gierer, D.O.University, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Vitamin D | Experimental | Dietary Supplement: Vitamin D (4,000 IU/day), Drug: OmalizumabParticipants receive high dose of Vitamin D (4,000 IU/day) in addition to standard of care dose of Omalizumab. |
| Low Dose Vitamin D | Active comparator | Dietary Supplement: Vitamin D (400 IU/day), Drug: OmalizumabParticipants receive low dose of Vitamin D (400 IU/day) in addition to standard of care dose of Omalizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician diagnosed chronic urticaria
- Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS <25
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D (4,000 IU/day)High Dose of 4,000 IU/day. | Dietary supplement | High Dose Vitamin D |
| Vitamin D (400 IU/day)Low Dose of 400 IU/day. | Dietary supplement | Low Dose Vitamin D |
| OmalizumabAlso: XolairStandard of care dose. | Drug | High Dose Vitamin D, Low Dose Vitamin D |
Primary outcome
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.
2 secondary outcomes
Number of subjects restarted on Omalizumab
Time frame: 8 Months
Change in total Urticaria Severity Score (USS)
Time frame: Change from Baseline to Month 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selina Gierer, D.O. principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D (4,000 IU/day), Vitamin D (400 IU/day) and Omalizumab in people with Urticaria, run by Selina Gierer, D.O. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total Urticaria Severity Score (USS) (time frame: Change from Baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.