Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
研究概览
简要总结
Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
详细描述
Children or adolescents with migraine and both parents are informed in detail about the study.Probands are advised to fill in a special childrens´ diary for migraine daily. After a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. Afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 3 days of migraine per month
排除标准
- •not able to communicate in german or english language
- •any disease that forbids the participation in the trial according to the investigators assessment
- •pregnancy
- •no willingness to participate in the trial
- •known allergy to fish or soya
结局指标
主要结局
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
时间窗: headaches before and after 12 weeks of treatment
次要结局
- frequency, duration and intensity of the migraine(before and after 12 weeks of treatment)