Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001195842
Ethics application status
Approved
Date submitted
8/10/2012
Date registered
13/11/2012
Date last updated
13/11/2012
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)
U1111-1135-3730
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

Intervention/exposure
Study type
Interventional
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
Prevention
Comparator / control treatment
Placebo (sucrose) control
Control group
Placebo

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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.
Pregnancy
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
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286106 0
Government body
Name [1] 286106 0
Smart Futures Fund
Country [1] 286106 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus, Griffith University, QLD, Australia, 4222
Country
Australia
Secondary sponsor category [1] 284918 0
None
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
Blackmore's
Address [1] 277113 0
20 Jubilee Avenue
Warriewood NSW 2102
Country [1] 277113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288153 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288153 0
Ethics committee country [1] 288153 0
Australia
Date submitted for ethics approval [1] 288153 0
Approval date [1] 288153 0
26/09/2012
Ethics approval number [1] 288153 0
MSC/15/12/HREC

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

Contacts
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
Australia
Phone 18033 0
+61 7 5552 9201
Fax 18033 0
Email 18033 0
[email protected]
Contact person for scientific queries
Name 8961 0
Michelle Hanna
Address 8961 0
Gold Coast Campus, Griffith University, 4222, QLD, Australia
Country 8961 0
Australia
Phone 8961 0
+61 7 5552 9201
Fax 8961 0
Email 8961 0
[email protected]

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.