title: Beneficial role for supplemental vitamin D3 treatment in chronic urticaria: a randomized study.
abstract: BACKGROUND
  Observational reports have linked vitamin D with chronic urticaria, yet no randomized controlled trial has been conducted.
  
  
  OBJECTIVE
  To determine whether high-dose vitamin D supplementation would decrease Urticaria Symptom Severity (USS) scores and medication burden in patients with chronic urticaria.
  
  
  METHODS
  In a prospective, double-blinded, single-center study, 42 subjects with chronic urticaria were randomized to high (4,000 IU/d) or low (600 IU/d) vitamin D3 supplementation for 12 weeks. All subjects were provided with a standardized triple-drug therapy (cetirizine, ranitidine, and montelukast) and a written action plan. Data on USS scores, medication use, blood for 25-hydroxyvitamin D, and safety measurements were collected.
  
  
  RESULTS
  Triple-drug therapy decreased total USS scores by 33% in the first week. There was a further significant decrease (40%) in total USS scores in the high, but not low, vitamin D3 treatment group by week 12. Compared with low treatment, the high treatment group demonstrated a trend (P = .052) toward lower total USS scores at week 12, which was driven by significant decreases in body distribution and number of days with hives. Beneficial trends for sleep quality and pruritus scores were observed with high vitamin D3. Serum 25-hydroxyvitamin D levels increased with high vitamin D3 supplementation, but there was no correlation between 25-hydroxyvitamin D levels and USS scores. There was no difference in allergy medication use between groups. No adverse events occurred.
  
  
  CONCLUSIONS
  Add-on therapy with high-dose vitamin D3 (4,000 IU/d) could be considered a safe and potentially beneficial immunomodulator in patients with chronic urticaria.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01371877.
authors: Pulmonary, Critical Care, Sleep, and Allergy Division, Department of Medicine, College of Medicine, University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska.
authors: Andy
authors: A
authors: Rorie
authors: Diabetes, Endocrinology and Metabolism Division, Department of Medicine, College of Medicine, University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska.
authors: Whitney S
authors: WS
authors: Goldner
authors: Department of Biostatistics, College of Public Health; University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska.
authors: Elizabeth
authors: E
authors: Lyden
authors: Pulmonary, Critical Care, Sleep, and Allergy Division, Department of Medicine, College of Medicine, University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska. Electronic address: japoole@unmc.edu.
authors: Jill A
authors: JA
authors: Poole
mesh_terms: D000085:Acetates / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D017332:Cetirizine / Q000008:administration & dosage; D002762:Cholecalciferol / Q000008:administration & dosage*; D002908:Chronic Disease; D003521:Cyclopropanes; D019587:Dietary Supplements; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage; D011899:Ranitidine / Q000008:administration & dosage; D013440:Sulfides; D014581:Urticaria / Q000178:diet therapy* / Q000188:drug therapy; D055815:Young Adult
chemical_list: D000085:Acetates; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D002762:Cholecalciferol; D011899:Ranitidine; C093875:montelukast; D017332:Cetirizine