Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
1 other identifier
interventional
76
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 2, 2010
February 1, 2010
1.1 years
November 9, 2009
February 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
frequency, duration and intensity of the migraine
before and after 12 weeks of treatment
Study Arms (1)
migraine dietary supplement
OTHERthe 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
Interventions
powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements
Eligibility Criteria
You may qualify if:
- at least 3 days of migraine per month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,
Essen, North Rhine-Westphalia, D-45147, Germany
Migräne und Kopfschmerzklinik Königstein
Königstein im Taunus, 61462, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charly Gaul, MD
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 10, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
April 1, 2011
Last Updated
February 2, 2010
Record last verified: 2010-02