Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000275268
Ethics application status
Approved
Date submitted
7/03/2009
Date registered
15/05/2009
Date last updated
11/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of vitamin supplementation, genotype and homocysteine on
migraine frequency and severity in females diagnosed with migraine with aura.
Scientific title
A Phase II randomised double-blind placebo-controlled clinical trial of vitamin supplementation in females diagnosed with migraine with aura, incorporating methylene tetrahydrofolate reductase (MTHFR) genotype analysis, to determine whether vitamin therapy is an effective complementary or alternative therapy for reducing migraine disability.
Secondary ID [1] 824 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine with aura 4435 0
Condition category
Condition code
Alternative and Complementary Medicine 4703 4703 0 0
Other alternative and complementary medicine
Neurological 5026 5026 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 months’ treatment with either B vitamins (25mg pyridoxine hydrochloride (HCl), folic acid 2mg, and vitamin B12 400mcg) or a placebo. Intervention dose: One trial tablet (B vitamin or Placebo) taken once daily for 12 months. Mode of administration: Oral tablet.
Intervention code [1] 4181 0
Treatment: Other
Comparator / control treatment
Placebo a)substance, sugar tablet; b) Mode of administration, oral tablet; c) Duration and frequency, one placebo tablet taken once daily for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 5571 0
To assess the effect of vitamin supplementation in migraine patients we will measure the 12-month retrospective migraine disability using the Migraine Disability Assessment Score (MIDAS) - a measure of migraine impact on quality of life. This post-treatment score will be compared to the baseline MIDAS score to establish the primary outcome variable (i.e. change in MIDAS score).
Timepoint [1] 5571 0
At zero year and at one year after randomisation.
Secondary outcome [1] 9382 0
Change in plasma homocysteine and vitamin levels will be assessed through a National Association of Testing Authorities (NATA) accredited laboratory using B6 plasma assay and homocysteine, folic acid and B12 serum assays.
Timepoint [1] 9382 0
At zero year and at one year after randomisation.

Eligibility
Key inclusion criteria
Female aged 18 to 65 years of age.
Have a diagnosis of migraine with aura (MA) according to International Headache Society Criteria.
Unrelated by first degree - we hypothesise that our outcome variable, response to vitamin therapy, is influenced by inherited factors, so genetic independence of participants is important.
Suffer at least 4 migraine episodes per year.
Of Caucasian ancestral background.
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.
Be able to attend the Genomics Research Centre (GRC) clinical trials facility on the Gold Coast.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participated in the migraine-vitamin trial pilot study.
Has a clinically recognised co-morbid disease e.g. vascular disease, depression, epilepsy.
Other severe illness that might interfere with assessment or hamper patient’s ability to complete the study e.g. compliance.
Pregnancy or planned pregnancy in the study period.
History of any psychiatric illness.
Inability to comply with treatment regime or attend clinic assessments.
Participation in another clinical trial or received experimental therapy within 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 and/or folic acid supplementation.
Persons who have ever been diagnosed with cancer.
Persons who have three or more first degree relatives who have been diagnosed with cancer.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4627 0
Charities/Societies/Foundations
Name [1] 4627 0
Nutricia Research Foundation
Country [1] 4627 0
Netherlands
Primary sponsor type
University
Name
Griffith University
Address
Office for Research, Bray Centre,
Nathan Campus, Griffith University
Nathan Queensland 4111
Country
Australia
Secondary sponsor category [1] 4171 0
None
Name [1] 4171 0
Address [1] 4171 0
Country [1] 4171 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6666 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 6666 0
Ethics committee country [1] 6666 0
Date submitted for ethics approval [1] 6666 0
Approval date [1] 6666 0
08/01/2009
Ethics approval number [1] 6666 0
MSC/09/05/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29363 0
Address 29363 0
Country 29363 0
Phone 29363 0
Fax 29363 0
Email 29363 0
Contact person for public queries
Name 12610 0
Shirley Wee
Address 12610 0
Clinical Trials Coordinator
Genomics Research Centre Clinic
School of Medical Science
G05, Rm 3.20 Griffith University
Parklands Drive, Southport
Queensland 4215
Country 12610 0
Australia
Phone 12610 0
61 7 55529773
Fax 12610 0
61 7 55529202
Email 12610 0
s.wee@griffith.edu.au
Contact person for scientific queries
Name 3538 0
Professor Lyn Griffiths
Address 3538 0
Director, Griffith Institute for Health and Medical Research
Dean, Research (Health)
Director, Genomics Research Centre
G05, Rm 2.11, Gold Coast campus,
Parklands Drive, Southport
GRIFFITH UNIVERSITY QLD 4215
Country 3538 0
Australia
Phone 3538 0
61 7 5552 8664
Fax 3538 0
61 7 5552 9081
Email 3538 0
l.griffiths@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.