A randomized, double-blinded, placebo-controlled, parallel trial of vitamin D₃ supplementation in adult patients with migraine

BACKGROUND: Vitamin D levels have been linked to certain pain states, including migraine. We investigated whether vitamin D supplementation would be beneficial for adult patients with migraine (ClinicalTrials.gov Identifier: NCT01695460).

METHODS: A randomized, double-blind, placebo-controlled parallel trial was conducted in migraine patients (36 women and 12 men, 18-65 years of age). A 4-week baseline period was conducted before randomization to 24 weeks of treatment. Participants were assigned to receive D3-Vitamin® (n = 24, 18 women and 6 men, 100 μg/day D3-Vitamin®) or placebo (n = 24, 18 women and 6 men). Migraine attacks and related symptoms were assessed by self-reported diaries. The response rate (i.e., experiencing a 50% or greater reduction in migraine frequency from baseline to week 24), change in migraine severity, and number of migraine days were recorded. Changes in migraine-related symptoms, HIT-6TM scores, and pain sensitivity tests (pressure pain threshold and temporal summation) were also evaluated. Serum levels of both 25(OH)D and 1,25(OH)2D were assessed from baseline to week 24.

RESULTS: The number of headache days changed from 6.14±3.60 in the treatment group and 5.72±4.52 in the placebo group at baseline to 3.28±3.24 and 4.93±3.24 by the end of the trial, respectively. Migraine patients on D3-Vitamin® demonstrated a significant decrease (p < 0.001) in migraine frequency from baseline to week 24 compared with placebo. However, migraine severity, pressure pain thresholds or temporal summation did not show a significant change. 25(OH)D levels increased significantly for the D3-Vitamin® group during the first 12 weeks of treatment. There was no significant change in 1,25(OH)2D. No side effects were reported or noted.

CONCLUSIONS: D3-Vitamin® was superior to placebo in reducing migraine days in migraine patients. Larger studies are required to confirm that vitamin D3 might be one of the prophylactic options for adult patients with migraine.