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

Complen Health

Status: Unknown

Conditions: Migraine

Treatments: Dietary Supplement: Migra 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010711

TOM-DS-CH-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

76 participants in 1 patient group

migraine dietary supplement

Other group

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

Treatment:

Dietary Supplement: Migra 3