Andy Rorie1, Whitney S Goldner2, Elizabeth Lyden3, Jill A Poole4. 1. Pulmonary, Critical Care, Sleep, and Allergy Division, Department of Medicine, College of Medicine, University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska. 2. Diabetes, Endocrinology and Metabolism Division, Department of Medicine, College of Medicine, University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska. 3. Department of Biostatistics, College of Public Health; University of Nebraska Medical Center, The Nebraska Medical Center, Omaha, Nebraska. 4. 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.
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. CONCLUSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01371877.
RCT Entities:
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. CONCLUSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01371877.
Authors: Roohi Rasool; Khalid Z Masoodi; Irfan A Shera; Qayser Yosuf; Imtiyaz A Bhat; Iqbal Qasim; Saniya Nissar; Zafar A Shah Journal: World Allergy Organ J Date: 2015-06-04 Impact factor: 4.084