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Evaluating the effects of vitamin B1, B6, B12 and folic acid supplementation in women with episodic migraine

Phase 3
Recruiting
Conditions
migraine headache.
Migraine
Registration Number
IRCT20190921044828N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
100
Inclusion Criteria

Body mass index 18.5-30
Aged 18-50 years old
Migraine diagnosis according to The Classification Committee of the International Headache Society (IHS) 3rd edition (beta version)
Episodic migraine with 3 attacks or more per month
Suffering from migraine for at least 6 months prior to study

Exclusion Criteria

Unwillingness to participate in the study
Taking vitamin B group supplements in 3 months prior to study
Pregnancy and lactation
Taking anti-psychotic drugs
Suffering from gastrointestinal disorders (malabsorption,IBD,...),diabetes, liver disorders(Cirrhosis, Hepatitis), kidney disorders(Kidney Failure), congestive heart failure, hypertension,cancer
Smoking
Changes in dosage and type of migrane prophylactic drugs during intervention
Not taking more than 10% of supplements

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Migraine attack frequency per month. Timepoint: baseline-end of study. Method of measurement: headache diary.;Attack severity. Timepoint: baseline-end of study. Method of measurement: headache diary-visual analogue scale.;Headache attack duration (min per month). Timepoint: baseline-end of study. Method of measurement: headache diary.
Secondary Outcome Measures
NameTimeMethod
Serum homocysteine. Timepoint: baseline- end of study. Method of measurement: ELISA KIT.;Serum endothelial nitric oxide synthase. Timepoint: baseline- end of study. Method of measurement: ELISA KIT.;Serum Calcitonin gene-related peptide (CGRP). Timepoint: baseline- end of study. Method of measurement: ELISA KIT.
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