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

Not Applicable

• Conditions: Migraine
• Interventions: Dietary Supplement: Migra 3

• Registration Number: NCT01010711
• Lead Sponsor: Complen Health GmbH

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-01
• Last Update Posted: 2010-02-02
• Primary Completion: 2010-12
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
migraine dietary supplement	Migra 3	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
frequency, duration and intensity of the migraine	before and after 12 weeks of treatment

Trial Locations

Locations (2)

Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Migräne und Kopfschmerzklinik Königstein; 🇩🇪 Königstein Im Taunus, Germany