Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents - Full Text View

Sponsor:	Complen Health GmbH
Information provided by:	Complen Health GmbH
ClinicalTrials.gov Identifier:	NCT01010711

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Dietary Supplements Headache Migraine

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

frequency, duration and intensity of the migraine [ Time Frame: before and after 12 weeks of treatment ] [ Designated as safety issue: Yes ]

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 Other Name: Migra 3

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

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Dr. Margarete Doppler, COMPLEN HEALTH GmbH
ClinicalTrials.gov Identifier:	NCT01010711 History of Changes
Other Study ID Numbers:	TOM-DS-CH-1
Study First Received:	November 9, 2009
Last Updated:	February 1, 2010
Health Authority:	Germany: Federal Ministry of Food, Agriculture and Consumer Protection

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

ClinicalTrials.gov processed this record on May 24, 2012