Vitamin D Levels in Subjects With Chronic Urticaria and Angioedema

NCT00876369 | Completed

• 1 other identifier: 0045-09-EP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urticaria; Angioedema

Keywords

urticaria; angioedema; vitamin D; allergy

Outcome Measures

Primary Outcomes (1)

• 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.

  one measurement

Study Arms (2)

Urticaria/Angioedema

Subjects with chronic urticaria and/or angioedema

allergy control

Subjects with physician diagnosed allergic rhinitis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects at subspeciality clinic (allergy/immunology) at tertiary care medical center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Urticaria; Angioedema; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jill A Poole, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 6, 2009
• Study Start: September 1, 2009
• Primary Completion: December 11, 2009
• Study Completion: December 11, 2009
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

US (1)