UrticariaNCT00876369
Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema
An observational study of Urticaria and Angioedema, run by University of Nebraska at 1 site in United States.
Trial summary
The objective of this study is to perform an exploratory analysis to determine if a possible relationship between vitamin D and chronic urticaria and/or angioedema exists. The study hypothesis is that vitamin D deficiency is associated with chronic urticaria and/or angioedema. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urticaria, Angioedema
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2009to 11 Dec 2009
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects at subspeciality clinic (allergy/immunology) at tertiary care medical center
Who may be able to join
- Group 1: subjects with physician-diagnosed allergic rhinitis. Allergic rhinitis is defined by clinical symptoms of sneezing, runny nose, nasal congestion and evidence of IgE-mediated disease (allergy skin prick test positive or radioallergosorbent test [RAST] positive to environmental inhalants such as trees, grasses, weeds, animal dander, molds, dust mite, cockroach).
- Group 2: subjects with physician-diagnosed chronic urticaria and/or angioedema (CUA). CUA is defined by having urticarial wheals (hives) and/or angioedema (dermal swelling) on a daily or almost daily for more than 6 weeks.
Who cannot join
- They are not capable of answering the questionnaire.
- They are diagnosed with hereditary angioedema. Hereditary angioedema is a genetic disorder, autosomal dominant, of the C1 esterase inhibitor protein. These subjects will be excluded as the etiology of their disease is known.
- Pregnant or lactating women. All child-bearing women will be asked (verbally and on the questionnaire) if they are pregnant or lactating. If they answer yes, they will be excluded. As there is no risk or harm to the pregnant or lactating woman, a urine pregnancy test will not be used.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The objective of this study is to perform an exploratory analysis to determine if a possible relationship between vitamin D and chronic urticaria and/or angioedema exists. The study hypothesis is that vitamin D deficiency is associated with chronic urticaria and/or angioedema.
Read the detailed description
The purpose of the research protocol is to perform a pilot study to determine the levels of 25-hydroxy vitamin D (25OHD), the storage form of vitamin D, in subjects with chronic urticaria and angioedema. Vitamin D is recognized as a key element in the regulation of the innate and adaptative immune system, and deficiencies of vitamin D could play an important role with inflammatory skin conditions such as chronic urticaria and angioedema.
Vitamin D deficiency has been implicated in contributing to the pathogenesis of skin inflammatory disorders including atopic dermatitis, rosacea and psoriasis. Deficiencies in vitamin D have recently been speculated to be associated with anaphylaxis diagnosis and treatment. The role of vitamin D in other allergic disorders such as allergic rhinitis is not clear. Chronic urticaria and angioedema (CUA) is a debilitating allergic disorder defined as recurrent urticaria and/or angioedema on a regular basis for greater than 6 weeks. The etiology of this disorder is largely unknown, but occurs predominately in females and can be associated with autoimmunity and thyroid disease. Vitamin D could potentially have an important role in the pathogenesis and treatment of CUA, but there are no studies to date examining the potential association of CUA and 25OHD levels.
This pilot study seeks to recruit two groups of adult subjects (ages 19 and up): 1) Control allergy group: subjects with physician-diagnosed allergic rhinitis, and 2) Subjects with physician-diagnosed chronic urticaria and/or angioedema. Subjects in the 2 groups will answer a questionnaire to collect information regarding demographics, vitamin D supplementation, previous diagnostic tests, current medications, and also a validated Dermatology Life Quality Index (attached). Other information will be obtained as available from the medical record: weight, height, body mass index (BMI), thyroid stimulating hormone (TSH), free thyroxine (T4), thyroid autoantibodies, urticaria autoimmune testing (autologous serum skin test, CD203c results), anti-nuclear antibody (ANA) and allergy skin prick testing. These stated tests are drawn for the evaluation of subjects with CUA. All subjects will have blood draw for 25OHD levels, and the levels will be compared between the 2 groups. It has been previously reported that approximately 15-30% of healthy populations are deficient in Vitamin D. There is no intervention component. Subjects will receive the 25OHD results, but no further follow-up is planned.
The objective of this pilot study is to perform an exploratory analysis to determine if a possible relationship between 25OHD and CUA exists, and to determine power calculations for a larger study. Finally, information regarding Vitamin D may be beneficial in determining potential contributing factors and also in the treatment of subjects with CUA.
- Conditions
- Urticaria, Angioedema
- Keywords
- urticaria, angioedema, vitamin D, allergy
- Medical subject headings
- Urticaria, Angioedema, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urticaria/Angioedema | Subjects with chronic urticaria and/or angioedema | |
| allergy control | Subjects with physician diagnosed allergic rhinitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
A one-time blood draw from participants in chronic urticaria and/or angioedema group and control allergic rhinitis group will compare 25-hydroxy vitamin D (25OHD) levels between the groups.
Measured: one measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study start1 Sep 2009
- Primary completion11 Dec 2009
- Study completion11 Dec 2009
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.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jill A Poole, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876369
- Sponsor's protocol ID
- 0045-09-EP
- Status last verified
- Sep 2023
- First submitted
- 2 Apr 2009
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema
- ClinicalTrials.gov ID
- NCT00876369
- Acronym / sponsor ID
- 0045-09-EP
- Conditions
- Urticaria, Angioedema
- Keywords
- urticaria, angioedema, vitamin D, allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 11 Dec 2009 (actual)
- Study completion
- 11 Dec 2009 (actual)
- First posted
- 6 Apr 2009 (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 objective of this study is to perform an exploratory analysis to determine if a possible relationship between vitamin D and chronic urticaria and/or angioedema exists. The study hypothesis is that vitamin D deficiency is associated with chronic urticaria and/or angioedema.
Detailed description
The purpose of the research protocol is to perform a pilot study to determine the levels of 25-hydroxy vitamin D (25OHD), the storage form of vitamin D, in subjects with chronic urticaria and angioedema. Vitamin D is recognized as a key element in the regulation of the innate and adaptative immune system, and deficiencies of vitamin D could play an important role with inflammatory skin conditions such as chronic urticaria and angioedema.
Vitamin D deficiency has been implicated in contributing to the pathogenesis of skin inflammatory disorders including atopic dermatitis, rosacea and psoriasis. Deficiencies in vitamin D have recently been speculated to be associated with anaphylaxis diagnosis and treatment. The role of vitamin D in other allergic disorders such as allergic rhinitis is not clear. Chronic urticaria and angioedema (CUA) is a debilitating allergic disorder defined as recurrent urticaria and/or angioedema on a regular basis for greater than 6 weeks. The etiology of this disorder is largely unknown, but occurs predominately in females and can be associated with autoimmunity and thyroid disease. Vitamin D could potentially have an important role in the pathogenesis and treatment of CUA, but there are no studies to date examining the potential association of CUA and 25OHD levels.
This pilot study seeks to recruit two groups of adult subjects (ages 19 and up): 1) Control allergy group: subjects with physician-diagnosed allergic rhinitis, and 2) Subjects with physician-diagnosed chronic urticaria and/or angioedema. Subjects in the 2 groups will answer a questionnaire to collect information regarding demographics, vitamin D supplementation, previous diagnostic tests, current medications, and also a validated Dermatology Life Quality Index (attached). Other information will be obtained as available from the medical record: weight, height, body mass index (BMI), thyroid stimulating hormone (TSH), free thyroxine (T4), thyroid autoantibodies, urticaria autoimmune testing (autologous serum skin test, CD203c results), anti-nuclear antibody (ANA) and allergy skin prick testing. These stated tests are drawn for the evaluation of subjects with CUA. All subjects will have blood draw for 25OHD levels, and the levels will be compared between the 2 groups. It has been previously reported that approximately 15-30% of healthy populations are deficient in Vitamin D. There is no intervention component. Subjects will receive the 25OHD results, but no further follow-up is planned.
The objective of this pilot study is to perform an exploratory analysis to determine if a possible relationship between 25OHD and CUA exists, and to determine power calculations for a larger study. Finally, information regarding Vitamin D may be beneficial in determining potential contributing factors and also in the treatment of subjects with CUA.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urticaria/Angioedema | – | –Subjects with chronic urticaria and/or angioedema |
| allergy control | – | –Subjects with physician diagnosed allergic rhinitis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects at subspeciality clinic (allergy/immunology) at tertiary care medical center
Key inclusion criteria (2 listed)
- Group 1: subjects with physician-diagnosed allergic rhinitis. Allergic rhinitis is defined by clinical symptoms of sneezing, runny nose, nasal congestion and evidence of IgE-mediated disease (allergy skin prick test positive or radioallergosorbent test [RAST] positive to environmental inhalants such as trees, grasses, weeds, animal dander, molds, dust mite, cockroach).
- Group 2: subjects with physician-diagnosed chronic urticaria and/or angioedema (CUA). CUA is defined by having urticarial wheals (hives) and/or angioedema (dermal swelling) on a daily or almost daily for more than 6 weeks.
Key exclusion criteria (3 listed)
- They are not capable of answering the questionnaire.
- They are diagnosed with hereditary angioedema. Hereditary angioedema is a genetic disorder, autosomal dominant, of the C1 esterase inhibitor protein. These subjects will be excluded as the etiology of their disease is known.
- Pregnant or lactating women. All child-bearing women will be asked (verbally and on the questionnaire) if they are pregnant or lactating. If they answer yes, they will be excluded. As there is no risk or harm to the pregnant or lactating woman, a urine pregnancy test will not be used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin D levels
Time frame: one measurement
A one-time blood draw from participants in chronic urticaria and/or angioedema group and control allergic rhinitis group will compare 25-hydroxy vitamin D (25OHD) levels between the groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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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.
Jill A Poole, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urticaria and Angioedema, run by University of Nebraska 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 3 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: finished, as of the sponsor's last update on 6 Sep 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vitamin D levels (time frame: one measurement). 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 6 Sep 2023.