A Nutritional Intervention for Migraines

Not Applicable

Completed

• Conditions: Migraines
• Interventions: Dietary Supplement: mixture of omega3 and vitamins; Other: Vegan Diet

• Registration Number: NCT01547494
• Lead Sponsor: Physicians Committee for Responsible Medicine

Brief Summary

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.

Detailed Description

Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. We will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders18

   • At least 5 attacks fulfilling criteria the criteria below

   • Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

   • Headache has at least two of the following characteristics:

     • unilateral location
     • pulsating quality
     • moderate or severe pain intensity
     • aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)

   • During headache at least one of the following:

     • nausea and/or vomiting
     • photophobia and phonophobia

   • Not attributed to another disorder

2. Migraines occurring at least twice per month, on average.

3. Age at least 18 years

4. Ability and willingness to participate in all components of the study

5. Willingness to be assigned to either the diet group or supplement group

6. Migraine medications unchanged within last 6 weeks.

Exclusion Criteria

1. < 18 years of age
2. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
3. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
4. Pregnancy
5. Unstable medical or psychiatric illness
6. Likely to be disruptive in group sessions (as determined by research staff)
7. Already following a low-fat, vegan diet
8. Lack of English fluency
9. Inability to maintain current medication regimen
10. Inability or unwillingness to participate in all components of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vegan Diet	mixture of omega3 and vitamins	-
Dietary Supplement	Vegan Diet	-

Primary Outcome Measures

Name	Time	Method
Migraines Pain Change in Migraines frequency	Baseline and 4 months	Pain as measured by VAS score
Change in Migraines frequency	Baseline and 4 months	the reduction in the number of migraine attacks.

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline and 4 months	Health related quality of life as measured by a questionnaire

Trial Locations

Locations (1)

Physicians Committee for Responsible Medicine; 🇺🇸 Washington, District of Columbia, United States