The effect of high-dose of vitamin B1 supplementation on serum CGRP neuropeptide levels and features of episodic migraine in women

Determining the effect of high-dose of vitamin B1 supplementation on serum CGRP neuropeptide level and features of episodic migraine in women.

Clinical trial with placebo control group, with parallel groups, double blinded, randomized, on 40 patients, randomization with blocks of size 4 using software

This study will be performed in Sina Hospital in Tehran. Before and after the intervention , demographic information, headache characteristics and anthropometric indicators are recorded. Patients will receive vitamin B1 supplements or placebo for 12 weeks. At the beginning and at the end of the study, a food and physical activity reminder questionnaire is completed. Also, serum levels of CGRP neuropeptide and serum B1 and activity level of red blood cell transketolase will be measured at the beginning and at the end of the study.

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), 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, Having known gastrointestinal diseases, diabetes, liver disorders, kidney disorders, congestive heart failure, high blood pressure, cancer.

Patients will receive 300 mg thiamine tablets (intervention group) or placebo (control group) 3 times daily (every 8 hours) for 12 weeks.

Number of headache attacks per month; Headache severity (VAS); Duration of headache attacks (hours per month)

The Block randomization method is used to randomize the patients. For randomization, we will visit www.sealedenvelope.com and use the randomization tab to make a list considering the number of intervention groups, sample size and block size (4 is selected for current study). The prepared list that contains the pattern of patient allocation will be obtained and used. this site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 40 patients (20 patients in the intervention group (A) and 20 patients in the control group (B)), 10 blocks with a volume of four includes two groups A and B will be randomly selected using the software, such as (BAAB), (ABBA), (AABB), (BBAA), (ABAB). Then 40 pockets (20 pockets containing paper containing A and 20 pockets containing B) will be prepared based on sample size. According to a list of blocks, a trained person outside of the research team will be set the row of pockets. After admission of each patient will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size.

It is a double blind study. A third person out of study team (clinic secretary) have the sequence of codes that provide the team with sealed pockets coded as A or B at the time of sampling. The following groups of people involved in the trial: participants, research team including principle investigator, data collectors, and outcome assessors will be blind. After analyzing the data investigators and outcome assessors will be unblinded about A and B group allocation to supplement and placebo. Patients in supplement and placebo groups will receive packages of similar capsules.

Coded data of the participants, study protocol, and report of the main output of the study would be available in case of researchers' reasonable request sending to principal investigator of the study 6 months after publishing the article.

Starting 6 months after publication

University researchers

No other criteria

Email to soodehrazeghi@gmail.com

Sending email to me