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

February 1, 2010 updated by: Complen Health GmbH

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Königstein Im Taunus, Germany, 61462
        • Recruiting
        • Migräne und Kopfschmerzklinik Königstein
        • Contact:
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, D-45147
        • Recruiting
        • Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,
        • Contact:
        • Sub-Investigator:
          • Dagny Holle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Dietary supplement: Migra 3
powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
Time Frame: headaches before and after 12 weeks of treatment
headaches before and after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
frequency, duration and intensity of the migraine
Time Frame: before and after 12 weeks of treatment
before and after 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complen Health GmbH

Investigators

  • Principal Investigator: Charly Gaul, MD, Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOM-DS-CH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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