Migraine | Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Migraine research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Migra 3powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
migraine dietary supplementthe 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
Start Date: November 2009
Completed Date: April 2011
Primary Outcome: number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
Secondary Outcome: frequency, duration and intensity of the migraine
Study sponsors, principal investigator, and references
Principal Investigator: Charly Gaul, MD
Lead Sponsor: Complen Health GmbH