Evaluating the effects of vitamin B1, B6, B12 and folic acid supplementation versus placebo on serum levels of CGRP, Nitric oxide, homocysteine and headache characteristics in women with episodic migraine
The aim of this double-blind randomized clinical trial is to determine the effects of vitamin B1, B6, B12 and folic acid supplementation versus placebo on serum levels of CGRP, Nitric oxide, homocysteine and headache characteristics in women with episodic migraine
Design
This study is a double-blind, randomized controlled clinical trial with 5 parallel groups. 100 patients will be randomly assigned into B1, B6, B12, folic acid and control group.
Settings and conduct
The study will perform at the tertiary headache clinic of Sina University Hospital. Information on demographic data and headache characteristics will be collected. After assessing the entrance criteria, 10 cc blood samples are taken. The food recall and physical activity questionnaire is completed. Anthropometric measurements and blood pressure are taken. Supplements are given to patients for a month. For double-blind implementation(patients and investigators), all boxes of supplements by a third party is coded as A, B, C, D, E.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Body mass index 18.5-30, Aged 18-50 years old, Having 3-15 migraine headache attacks in last 3 months
Exclusion critera: Unwillingness to participate in the study, Changes in dosage and type of migrane prophylactic drugs during intervention
Intervention groups
Intervention groups: B1, B6, B12, folic acid tablet; Control group: placebo tablet. Patients in the B1, B6, B12, folic acid group will receive 1 tablet per day, each containing 300mg, 80mg, 500mcg and 2mg ,respectively for 12 weeks. Patients in the control group will receive 1 tablets of placebo containing Methylcellulose per day.
Main outcome variables
headache attack frequency per month; headache severity (VAS); attack duration (min per month)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190921044828N1
Registration date:2019-09-26, 1398/07/04
Registration timing:prospective
Last update:2019-09-26, 1398/07/04
Update count:1
Registration date
2019-09-26, 1398/07/04
Registrant information
Name
Shiva Nematgorgani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4489 9564
Email address
shiva.gorgani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of vitamin B1, B6, B12 and folic acid supplementation versus placebo on serum levels of CGRP, Nitric oxide, homocysteine and headache characteristics in women with episodic migraine
Public title
Evaluating the effects of vitamin B1, B6, B12 and folic acid supplementation in women with episodic migraine
Purpose
Treatment
Inclusion/Exclusion criteria
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)
Having 3-15 migraine headache attacks in last 3 months
Suffering from migraine for at least 3 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
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients on the basis of random allocation rule method are randomly assigned to the 5 groups; B1, B6, B12, folic acid and placebo. In this study, In this study, 20 codes for each group is placed in a drawing container and then the codes are randomly ejected from the container without replacement and the created sequences are recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing B1, B6, B12, folic acid or placebo by a third party (someone other than the researchers) is coded as A, B, C, D and E.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti medical university
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods,