Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents

Conditions
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Migraine

Intervention / Treatment
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* Dietary Supplement: Migra 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 3 days of migraine per month Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: migraine dietary supplement<br>the average days of migraine during a 4 week-run-in-period are compared with the average days of migraine during intervention with a specific dietary supplement from week 8 - 12 | Dietary Supplement: Migra 3<br>* powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement |  | headaches before and after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency, duration and intensity of the migraine |  | before and after 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, children, dietary supplement, q10, prevention