Role of vitamin D in chronic urticaria and angioedema treatment study: Enrollment characteristics

Chronic urticaria and/or angioedema is defined as recurrent hives with pruritus and/or dermal swelling for at least 6 weeks. Despite extensive evaluation for underlying causes/triggers, etiology remains largely idiopathic and treatment options are limited. Recently, low serum 25 hydroxy vitamin D (25OHD) levels were associated with chronic urticaria, and observational studies found benefit with vitamin D supplementation in deficient subjects. We designed a prospective, double-blinded study to enroll subjects with chronic urticaria with or without vitamin D deficiency to be randomized to vitamin D 600 IU or 4000 IU daily for 12 weeks with approval obtained from institution's IRB and informed consent obtained from all research subjects. Since initiation (November 2011), 22 of the 39 subjects have been enrolled with mean (SD) age of 44.1 (12.4) years and body mass index of 34.0 (8.3). Further baseline characteristics include: female (77%), allergic sensitization to > 1 allergen (41%), history of tobacco use (45.45%), history of alcohol-exacerbating hives (27.27%), hypothyroidism (31.82%), thyroid autoimmunity (23%), urticaria autoimmunity as defined by %CD203c greater than 5% (32%), and anti-nuclear antibody (ANA) positive (23%). The mean (SD) level of serum 25OHD (ng/ml) is 27.2 (10.1) (normal range, 30-200 ng/ml). The baseline total urticaria severity score is 44.8 (10.9) (potential range is 0-93). Subjects were taking a mean (SD) of 3.8 (2.6) pills/daily for symptoms. None of the enrollment characteristics were associated with baseline serum 25OHD levels as determined by Spearman correlation coefficients. In summary, enrollment has been initiated in this ACAAIfunded study, and moreover, subjects fit the typical patient phenotype and demonstrate low serum 25OHD levels.