Omega-3 Fatty Acid in the Prevention of Migraine

NCT04572789 | Completed

• 1 other identifier: 10844
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To understand the clinical efficacy for omega-3 PUFAs migraine prevention.To uncover the underlying biochemical or neurophysiological mechanisms by which omega-3 PUFAs for migraine prevention.

Conditions

Migraine; Omega-3 Polyunsaturated Fatty Acids

Outcome Measures

Primary Outcomes (1)

• Reduction of migraine attacks during the 12-week period [Efficacy]

  The primary end point is the mean change from baseline (28-day pretreatment period) in the mean number of monthly migraine days during the 12-week period. A migraine day was defined as (a day with headache pain that lasted 4 hours with a peak severity of moderate or severe intensity, or any severity or duration if the participant took and responded to a triptan or ergot) from the second to the fourth diaries compared with the first diary (baseline period).

  12 weeks

Secondary Outcomes (9)

• 50% reduction of migraine attacks

  12 weeks

• Migraine Disability Assessment Score (MIDAS)

  12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  12 weeks

• The Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S)

  12 weeks

• The Beck Depression Inventory-II (BDI-II)

  12 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.

Dietary Supplement: omega-6 PUFAs

Omega-3

EXPERIMENTAL

All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.

Dietary Supplement: Omega-3 polyunsaturated fatty acids

Interventions

Omega-3 polyunsaturated fatty acids DIETARY_SUPPLEMENT

All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of omega-3 PUFAs intervention (EPA, 1.8 g/day) and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.

Omega-3

omega-6 PUFAs DIETARY_SUPPLEMENT

All participants will complete a set of outcome measures at baseline and the follow-up visits before and after 12 weeks of placebo omega-6 PUFAs intervention and a series of blood tests for neurotransmitter, neurotrophic and neuroinflammation. The clinical efficacy and the peripheral blood biomarkers, will be analyzed at baseline and the end of the intervention.

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20 to 65 years old
• A diagnosis based on the International Classification of Headache Disorders (ICHD-3)
• An established migraine history for at least 1 year
• Independent from the study
• Written informed consent

You may not qualify if:

• Chronic migraine
• Headaches other than migraine
• Use any of the following drugs in the past four weeks：
• Migraine prophylaxis agents
• Anti-depressants
• Calcium channel blockers
• Anti-epileptic agents
• Cycle-modulating hormonal drugs
• Onabotulinumtoxin A (Botox) injection
• Migraine onset after the age of 50
• Emerging abnormal findings on：
• Laboratory parameters
• Physical examination
• Suicidal risks
• Severe depression

Sponsors & Collaborators

• Kuang Tien General Hospital: lead

Study Sites (1)

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-6

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Chun-Pai Yang, Dr.

  Neurology department of Kuang Tien General hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 1, 2020
• Study Start: December 3, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)