Effects of probiotic and vitamin D co-supplementation on migraine index, quality of life, and oxidative stress in adults with migraine headache: a randomized triple-blinded clinical trial
Abstract
Background: The current study was conducted to assess the effect of probiotic and vitamin D co-supplementation on migraine index (MI), migraine-specific quality of life (MSQoL), and oxidative stress in adults with migraine.
Methods: This parallel randomized, triple-blinded, placebo-controlled trial was conducted among adult individuals aged 18 to 55 years with a diagnosis of migraine headache according to the International Classification of Headache Disorders-3 (ICHD-3). Patients were randomized to either multispecies probiotic (4.5 × 1011 CFU per day) plus vitamin D (50,000 IU every two weeks) or placebo for 12 weeks. MI, MSQoL, blood pressure, anthropometric, and biochemical variables (25-hydroxy vitamin D, nitric oxide (NO), malondialdehyde (MDA), total oxidative status (TOS), total antioxidant capacity (TAC), and catalase (CAT)) were examined at baseline and after 12 weeks of intervention.
Results: In total, 72 patients (36 patients in each group) with migraine headache were included in the study. The mean age of patients was 37.46 ± 0.98 and sixty five out of 72 patients were females. A significant increase in mean serum levels of 25-hydroxy vitamin D was observed in the probiotic plus vitamin D group compared to the placebo group (p < 0.001). A significantly greater reduction in mean MI (-30.11 ± 6.95 vs. -11.97 ± 3.05; p = 0.01) was found in the probiotic plus vitamin D than in the placebo group. In addition, a marginally significant difference was observed between…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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