ACTRN12609000275268
已完成
未知
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.
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Migraine with aura
- 发起方
- Griffith University
- 入组人数
- 250
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
未指定
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