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IRCT20140804018677N24 IRCT 2023-03-11 Shahid Beheshti University of Medical Sciences, Nutrition and Food Industries Research Institute The effect of high-dose of vitamin B1 supplementation on episodic migraine in women The effect of high-dose of vitamin B1 supplementation on serum CGRP neuropeptide levels and features of episodic migraine in women 2023-05-21 anticipated 40 Complete https://irct.ir/trial/68806 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Episodic Migraine. Intervention 1: Intervention group: Thiamin (300 mg), dana darou company, three times daily for 12 weeks. Intervention 2: Control group: Placebo (300 mg), dana darou company, three times daily for 12 weeks. Yes - There is a plan to make this available What will be shared: 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. When: Starting 6 months after publication To whom: University researchers Conditions: No other criteria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: Sending email to me Comments:
public Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female 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 G43 Migraine Treatment - Other Placebo Intervention group: Thiamin (300 mg), dana darou company, three times daily for 12 weeks Control group: Placebo (300 mg), dana darou company, three times daily for 12 weeks Number 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. Number 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. Shahid Beheshti University of Medical Sciences, Faculty of Nutrition Sciences and Food Industries, Nutrition and Food Industries Research Institute Approved 2023-01-22 Ethics committee of Nutrition and Food Industry Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town, Tehran Tehran Tehran Iran (Islamic Republic of)