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

NCT ID: NCT01010711

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

migraine dietary supplement

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

Group Type OTHER

Migra 3

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Migra 3

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Complen Health GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

COMPLEN HEALTH GmbH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Charly Gaul, MD

Role: PRINCIPAL_INVESTIGATOR

Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Migräne und Kopfschmerzklinik Königstein

Königstein im Taunus, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Charly Gaul, MD

Role: CONTACT

0049-201-43696-0

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Charly Gaul, MD

Role: primary

0049-201-43696-0

Dr. Jan Brand, Dr.

Role: primary

0049-6174-29040

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TOM-DS-CH-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Migraine Manager (R01)
NCT04567355 RECRUITING PHASE2