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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of a Vitamin B nutraceutical to treat migraine
Scientific title
A study in migraine sufferers using B group vitamins in a double-blind placebo controlled study to determine effective doses for reduction of migraine morbidity.
Secondary ID [1] 281334 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 287557 0
Condition category
Condition code
Neurological 287882 287882 0 0
Other neurological disorders
Alternative and Complementary Medicine 288154 288154 0 0
Other alternative and complementary medicine

Study type
Description of intervention(s) / exposure
B group vitamins by daily oral pill. Treatment will continue for six months.
Arm 1: Vitamin B6 (25mg/day), Vitamin B12 (400mcg/day), Folate (2mg/day).
Arm 2: Vitamin B6 (12.5mg/day), Vitamin B12 (400mcg/day), Folate (1mg/day).
Intervention code [1] 285797 0
Treatment: Drugs
Intervention code [2] 286052 0
Comparator / control treatment
Placebo (sucrose) control
Control group

Primary outcome [1] 288099 0
Reduction in migraine pain and/or frequency as reported by participant self-assessment in daily migraine diary.
Timepoint [1] 288099 0
6 Months
Secondary outcome [1] 299428 0
Lack of adverse events. No neurological symptoms, muscle weakness, pain, tics seizures or similar. Symptoms will be assessed by participant reporting and enquiry by trial staff at follow-up.
Timepoint [1] 299428 0
6 Months
Secondary outcome [2] 299945 0
Effect of genotypes of homocysteine pathway genes on response to treatment and dose (as reported by participant self-assessment in daily migraine diary). Genotypes detected using PCR based methodologies and/or DNA sequencing.
Timepoint [2] 299945 0
6 Months

Key inclusion criteria
18 to 65 years of age.
Male or female.
Have a diagnosis of migraine with aura according to International Headache Society Criteria
Participants with adequate venous access in their left and right arms to allow collection of a number of blood samples via venepuncture
Fluent in the English language.
Have voluntarily given written informed consent to participate in this study.
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Other definable cause for clinical presentation (i.e. not migraine).
Other severe illness or use of medication that might interfere with assessment or hamper patients ability to complete the study.
History of any psychiatric illness which may impair the ability to provide written informed consent.
Poor compliers or those unlikely to attend.
Participation in a clinical trial, or has received any experimental therapy, within the last 30 days.
Donated or lost a significant amount of blood (e.g. 550 mL) within the past 12 weeks.
Persons already taking vitamin B supplementation

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteer subjects will be screened for eligibility and those who qualify will be sent informed consent materials. Consenting participants will then be assigned a study number for randomisation by a central computer to conceal thier allocation.

After randomisation, consenting participants will be sent their clinical trial pack, consisting of blinded study medication (placebo, low dose or high dose) diet diary, medication diary, blood collection forms and migraine diary. Trial then commences with 6 weekly followups to test for compliance and medication status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
From the total participant pool for each sex, placebo, low dose and high dose places have been randomised to different participant numbers. Randomisation will be via simple randomisation by computer generated tables. As participants commence the study, they will be assigned the next number and thus enter the treatment goup randomly selected for that number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286106 0
Government body
Name [1] 286106 0
Smart Futures Fund
Address [1] 286106 0
Department of Science, Information Technology, Innovation and Arts
GPO Box 5078
Brisbane QLD 4001
Country [1] 286106 0
Primary sponsor type
Griffith University
Gold Coast Campus, Griffith University, QLD, Australia, 4222
Secondary sponsor category [1] 284918 0
Name [1] 284918 0
Address [1] 284918 0
Country [1] 284918 0
Other collaborator category [1] 277113 0
Commercial sector/Industry
Name [1] 277113 0
Address [1] 277113 0
20 Jubilee Avenue
Warriewood NSW 2102
Country [1] 277113 0

Ethics approval
Ethics application status
Ethics committee name [1] 288153 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288153 0
Nathan Campus, Griffith University, QLD, 4222
Ethics committee country [1] 288153 0
Date submitted for ethics approval [1] 288153 0
Approval date [1] 288153 0
Ethics approval number [1] 288153 0

Brief summary
This trial intends to determine whether the use of vitamin B can be used as an effective treatment for migraine. This trial will compare the migraine outcomes in those taking low or high doses of the vitamins versus people taking mock medication.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34786 0
Address 34786 0
Country 34786 0
Phone 34786 0
Fax 34786 0
Email 34786 0
Contact person for public queries
Name 18033 0
Michelle Hanna
Address 18033 0
Gold Coast Campus, Griffith University, 4222, QLD, Australia
Country 18033 0
Phone 18033 0
+61 7 5552 9201
Fax 18033 0
Email 18033 0
Contact person for scientific queries
Name 8961 0
Michelle Hanna
Address 8961 0
Gold Coast Campus, Griffith University, 4222, QLD, Australia
Country 8961 0
Phone 8961 0
+61 7 5552 9201
Fax 8961 0
Email 8961 0

No information has been provided regarding IPD availability
Summary results
No Results