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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01010711
• Other study ID #: TOM-DS-CH-1
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2009
• Last updated: February 1, 2010
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2010
• Source: Complen Health GmbH
• Contact: Charly Gaul, MD
• Phone: 0049-201-43696-0
• Email: Charly.Gaul[@]gmx.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• Migra 3
powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements

Locations

Country	Name	City	State
Germany	Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,	Essen	Nordrhein-Westfalen
Germany	Migräne und Kopfschmerzklinik Königstein	Königstein Im Taunus

Sponsors (1)

Lead Sponsor	Collaborator
Complen Health GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	frequency, duration and intensity of the migraine		before and after 12 weeks of treatment	Yes