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

Evaluating the effects of vitamin B1, B6, B12 and folic acid supplementation versus placebo on serum levels of CGRP, endothelial nitric oxide synthase, homocysteine and headache characteristics in women with episodic migraine

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190921044828N1

Enrollment

100

Registered

2019-09-26

Start date

2019-10-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine headache. Migraine

Interventions

Intervention 1: Intervention group: 1. B1(300 mg), 2. B6 (80 mg), 3. B12 (500mcg), 4. folic acid (2mg). Intervention 2: Control group: placebo.

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion 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) Episodic migraine with 3 attacks or more per month Suffering from migraine for at least 6 months prior to study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShiva Nematgorgani

Shahid Beheshti University of Medical Sciences

shiva.gorgani@gmail.com+98 21 4489 9564

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026