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Rorie A, Goldner B, Lyden MS, Poole JA. Beneficial role of supplemental vitamin D3 treatment in chronic urticaria: a randomized trial. All Asthma Immunol. 2014; Epub before print.
design
Single-center, prospective, randomized, double-blind study with 2 arms. Participants in Arm 1 were administered 4,000 IU vitamin D orally. Participants in Arm 2 received 600 IU per day. The study duration was 12 weeks and all participants used standard triple therapy (certrizine, ranitidine, montelukast) as needed.
Participant
The study included 42 participants who had suffered from idiopathic urticaria and/or idiopathic angioedema for at least 6 weeks. Exclusion criteria included physical urticaria (known physical trigger identified), hereditary or acquired angioedema, hypercalcemia, renal insufficiency, primary hyperparathyroidism, sarcoidosis, granulomatous disease, malignancy, or pregnancy/breastfeeding.
Evaluated study parameters
Medication intake, severity of urticaria
Primary outcome measures
Urticaria Severity Score (USS). Number and type of medications used (H1, H2 receptor antagonists, leukotriene antagonists)
Key findings
Triple therapy resulted in significant symptom relief within one week and reduced total USS scores by 33% in both arms. The addition of 4,000 IU/day of vitamin D was safe and provided additional symptom relief, with a 40% reduction in total USS values at 12 weeks. The high-dose vitamin D arm showed a trend (P=0.052) towards lower USS values compared to the low dose group at week 12, with lower urticaria body distribution and fewer hives days. In addition, participants reported better sleep and less severe itching in the high-dose group compared to the low-dose group. While serum levels of 25-hydroxycholecalciferol were generally higher in the high-dose group, there was no direct association with vitamin D levels and symptom improvement (USS scores). The use of allergy medication did not differ between the groups.
Effects on practice
Vitamin D deficiency is associated with asthma and atopic diseases.1.2This connection is biologically plausible; However, existing clinical data are full of contradictory reports.3.4There are currently insufficient data on the possible cause of D deficiency and the clinical value of vitamin D supplementation in certain allergic and atopic health conditions.
This is the first RCT on chronic idiopathic urticaria. In this study, the final USS values of 24.1 (4.0) for the low dose and 15.0 (2.9) only suggest that they are significant (P=0.052) The study has two major limitations: 1) the sample size was small and 2) mean 25(OH)D values were significantly higher in the low-dose group (37 ng/ml) than in the high-dose group (29 ng/ml) at baseline. At the end of the study, the low-dose group remained unchanged and the high-dose group increased to a mean of 56 ng/ml.
A value of 37 ng/ml (baseline mean of the low-dose group) with a small standard deviation is considered a vitamin D saturated population. This is a setup for a classic Type II false-negative study. That is, adding a group with normal values may not result in improvement. The unsurpassed serum levels at the start of the study suggested a negative study. This problem could have been solved if the study had lasted longer or if the participants had been divided into appropriate arms.
This study definitely supports triple therapy for providing relief to patients. This study suggests that adding 4,000 IU of vitamin D may provide additional relief. The results are not a home run. Doctors can provide significant additional relief by focusing on bowel function and adverse food reactions.