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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01010711
Enrollment
76
Registered
2009-11-10
Start date
2009-11-30
Completion date
2011-04-30
Last updated
2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

migraine, children, dietary supplement, q10, prevention

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.

Interventions

DIETARY_SUPPLEMENTMigra 3

powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements

Sponsors

Complen Health GmbH
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplementheadaches before and after 12 weeks of treatment

Secondary

MeasureTime frame
frequency, duration and intensity of the migrainebefore and after 12 weeks of treatment

Countries

Germany

Contacts

Primary ContactCharly Gaul, MD
Charly.Gaul@gmx.de0049-201-43696-0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026