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The effect of folic acid and pyridoxine supplementation on symptoms of migraine

Phase 1
Conditions
Migraine with aura.
Migraine with aura [classical migraine]
Registration Number
IRCT2013060411763N9
Lead Sponsor
Research Deputy of Isfahan University of Medical Sciences
Brief Summary

Introduction: Migraine is a neurovascular disease that affects the 10-20% of population worldwide. Studies have shown that migraine is associated with high level of homocysteine and lowering of this level can decrease the migraine symptoms. The aim of this study is to assess the effect of folate and pyridoxine supplementation on migraine symptoms in patients with migraine.<br /> Material and methods: One hundred twenty four migraine patients randomly assigned to four groups (folate+ pyridoxine, pyridoxine, folate and placebo). Migraine symptoms including headache severity, attacks and frequency and duration, and headache diary result (HDR) were assessed at the beginning and end of study. Multivariate analysis of covariance (MANCOVA) was used to determine the effect of supplements intake on migraine symptoms. <br /> Findings: in this study, migraine symptoms including severity, frequency, duration and HDR in pyridoxine +folate group compared with placebo group (p < 0.05). Such reduction was not observed in pyridoxine and folate group compared with placebo (p > 0.05). Although, severity and frequency of attacks reduced significantly in pyridoxine group compared with placebo group (p < 0.05).<br /> Discussion and conclusion: Combined pyridoxine and folate intake can decrease migraine symptoms including severity, frequency, duration and HDR. Further studies are needed to confirm our finding and also to determine the effective doses of vitamins.<br />

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
120
Inclusion Criteria

Patients suffered from migraine in a long time with current diagnosis of MA and a one-year history of severe; recurrent attacks(1 to 8 attacks per month) were selected; The patients with chronic heart disease; previous stroke incidence; chronic renal failure and also with history of taking vitamin B supplements were excluded from the study.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: VAS scale.;Frequency of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: Questionnaire.;Duration of migraine attacks. Timepoint: First and end of intervention (3 month). Method of measurement: Questionnaire.;Homocysteine level. Timepoint: First and end of intervention (3 month). Method of measurement: Laboratory analysis ( blood test).;Crp level. Timepoint: First and end of intervention (3 month). Method of measurement: Laboratory analysis ( blood test).
Secondary Outcome Measures
NameTimeMethod
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