The effect of high-dose of vitamin B1 supplementation on episodic migraine in wome

Phase 3

Conditions: Episodic Migraine.
Migraine

Registration Number: IRCT20140804018677N24

Lead Sponsor: Shahid Beheshti University of Medical Sciences, Nutrition and Food Industries Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: 40

Inclusion Criteria

Willingness to participate in the study
18 to 45 years old
BMI between 18.5-30
Diagnosis of episodic migraine headache based on the criteria of the Classification Committee of the International Headache Society (IHS) 3rd edition (beta version)
Suffering from headache for more than three months
Not taking a new medication to prevent migraine headache or changing its dose in the last 2 months

Exclusion Criteria

Vitamin B1 supplement consumption with any dose and consumption of any type of multivitamin containing vitamin B1 during the last three months
Pregnancy and lactation
Use of antipsychotic drugs
Smoking
Having known gastrointestinal diseases (malabsorption, IBD, etc.), diabetes, liver disorders (cirrhosis and types of hepatitis), kidney disorders (renal failure), congestive heart failure, high blood pressure, cancer

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of headache attacks per month. Timepoint: Baseline and at the end of the study. Method of measurement: Daily headache registration questionnaire.;Severity of headache attacks. Timepoint: Baseline and at the end of the study. Method of measurement: Daily headache registration questionnaire - visual analog scale.;Duration of headache attacks. Timepoint: Baseline and at the end of the study. Method of measurement: Daily headache registration questionnaire.

Secondary Outcome Measures

Name	Time	Method
umber and dose of painkillers. Timepoint: Baseline and at the end of the study. Method of measurement: Daily headache registration questionnaire.;Serum Calcitonin gene-related peptide (CGRP) level. Timepoint: Baseline and at the end of the study. Method of measurement: Blood test.;The activity level of Erythrocyte transketolase enzyme. Timepoint: Baseline and at the end of the study. Method of measurement: Blood test.;Serum vitamin B1 level. Timepoint: Baseline and at the end of the study. Method of measurement: Blood test.