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

Primary Purpose

Migraine

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Migra 3
Sponsored by
Complen Health GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, children, dietary supplement, q10, prevention

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,Recruiting
  • Migräne und Kopfschmerzklinik KönigsteinRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

migraine dietary supplement

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

frequency, duration and intensity of the migraine

Full Information

First Posted
November 9, 2009
Last Updated
February 1, 2010
Sponsor
Complen Health GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01010711
Brief Title
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Official Title
Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Complen Health GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, children, dietary supplement, q10, prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
migraine dietary supplement
Arm Type
Other
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Migra 3
Intervention Description
powder containing coenzyme q10, blueberries, black current, vitamins, magnesium,trace elements
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
frequency, duration and intensity of the migraine
Time Frame
before and after 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charly Gaul, MD
Phone
0049-201-43696-0
Email
Charly.Gaul@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charly Gaul, MD
Organizational Affiliation
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D-45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charly Gaul, MD
Phone
0049-201-43696-0
Email
Charly.Gaul@gmx.de
First Name & Middle Initial & Last Name & Degree
Dagny Holle, MD
Facility Name
Migräne und Kopfschmerzklinik Königstein
City
Königstein Im Taunus
ZIP/Postal Code
61462
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Jan Brand, Dr.
Phone
0049-6174-29040
Email
info@migraene-klinik.de

12. IPD Sharing Statement

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

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