RecruitingPhase 2ACTRN12612001195842

The use of a Vitamin B nutraceutical to treat migraine

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.

Sponsor

Griffith University

Enrollment

400 participants

Start Date

Oct 1, 2012

Study Type

Interventional

Conditions

Migraine

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing whether vitamin B supplements can reduce the frequency or severity of migraines. Migraines are intense headaches that can be debilitating, and current treatments do not work for everyone. The study compares two different doses of B vitamins against a placebo (a dummy pill with no active ingredient) to see which, if any, works best. You may be eligible if: - You are between 18 and 65 years old - You have been officially diagnosed with migraine with aura (a specific type of migraine) - You are fluent in English - You are not currently taking vitamin B supplements You may NOT be eligible if: - Your headaches have a cause other than migraine - You are pregnant - You have a psychiatric illness that would affect your ability to consent - You have participated in another clinical trial in the past 30 days - You have donated a large amount of blood in the past 12 weeks - You are already taking vitamin B supplements Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 (4

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).