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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Complen Health GmbH.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010711
First Posted: November 10, 2009
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Complen Health GmbH
  Purpose
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).

Condition Intervention
Migraine Dietary Supplement: Migra 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Complen Health GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • frequency, duration and intensity of the migraine [ Time Frame: before and after 12 weeks of treatment ]

Estimated Enrollment: 76
Study Start Date: November 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010711


Contacts
Contact: Charly Gaul, MD 0049-201-43696-0 Charly.Gaul@gmx.de

Locations
Germany
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, Recruiting
Essen, Nordrhein-Westfalen, Germany, D-45147
Contact: Charly Gaul, MD    0049-201-43696-0    Charly.Gaul@gmx.de   
Sub-Investigator: Dagny Holle, MD         
Migräne und Kopfschmerzklinik Königstein Recruiting
Königstein Im Taunus, Germany, 61462
Contact: Dr. Jan Brand, Dr.    0049-6174-29040    info@migraene-klinik.de   
Sponsors and Collaborators
Complen Health GmbH
Investigators
Principal Investigator: Charly Gaul, MD Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
  More Information

Responsible Party: Dr. Margarete Doppler, COMPLEN HEALTH GmbH
ClinicalTrials.gov Identifier: NCT01010711     History of Changes
Other Study ID Numbers: TOM-DS-CH-1
First Submitted: November 9, 2009
First Posted: November 10, 2009
Last Update Posted: February 2, 2010
Last Verified: February 2010

Keywords provided by Complen Health GmbH:
migraine
children
dietary supplement
q10
prevention

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases