A Nutritional Intervention for Migraines
Primary Purpose
Migraines
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vegan Diet
mixture of omega3 and vitamins
Sponsored by
About this trial
This is an interventional supportive care trial for Migraines focused on measuring Migraines, Diet, Vegetarian, Diet, Fat-Restricted, Pain
Eligibility Criteria
Inclusion Criteria:
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
- Migraines occurring at least twice per month, on average.
- Age at least 18 years
- Ability and willingness to participate in all components of the study
- Willingness to be assigned to either the diet group or supplement group
- Migraine medications unchanged within last 6 weeks.
Exclusion Criteria:
- < 18 years of age
- 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
- Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
- Pregnancy
- Unstable medical or psychiatric illness
- Likely to be disruptive in group sessions (as determined by research staff)
- Already following a low-fat, vegan diet
- Lack of English fluency
- Inability to maintain current medication regimen
- Inability or unwillingness to participate in all components of the study
Sites / Locations
- Physicians Committee for Responsible Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Dietary Supplement
Vegan Diet
Arm Description
Outcomes
Primary Outcome Measures
Migraines Pain Change in Migraines frequency
Pain as measured by VAS score
Change in Migraines frequency
the reduction in the number of migraine attacks.
Secondary Outcome Measures
Quality of life
Health related quality of life as measured by a questionnaire
Full Information
NCT ID
NCT01547494
First Posted
February 27, 2012
Last Updated
May 13, 2013
Sponsor
Physicians Committee for Responsible Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01547494
Brief Title
A Nutritional Intervention for Migraines
Official Title
A Nutritional Intervention for Migraines
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physicians Committee for Responsible Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraines
Keywords
Migraines, Diet, Vegetarian, Diet, Fat-Restricted, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Supplement
Arm Type
Placebo Comparator
Arm Title
Vegan Diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Vegan Diet
Intervention Description
Vegan diet, which is devoid of animal products and minimal in fat
Intervention Type
Dietary Supplement
Intervention Name(s)
mixture of omega3 and vitamins
Intervention Description
mixture of omega3 and vitamins
Primary Outcome Measure Information:
Title
Migraines Pain Change in Migraines frequency
Description
Pain as measured by VAS score
Time Frame
Baseline and 4 months
Title
Change in Migraines frequency
Description
the reduction in the number of migraine attacks.
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Health related quality of life as measured by a questionnaire
Time Frame
Baseline and 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Migraines occurring at least twice per month, on average.
Age at least 18 years
Ability and willingness to participate in all components of the study
Willingness to be assigned to either the diet group or supplement group
Migraine medications unchanged within last 6 weeks.
Exclusion Criteria:
< 18 years of age
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
Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
Pregnancy
Unstable medical or psychiatric illness
Likely to be disruptive in group sessions (as determined by research staff)
Already following a low-fat, vegan diet
Lack of English fluency
Inability to maintain current medication regimen
Inability or unwillingness to participate in all components of the study
Facility Information:
Facility Name
Physicians Committee for Responsible Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25339342
Citation
Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain. 2014 Oct 23;15(1):69. doi: 10.1186/1129-2377-15-69.
Results Reference
derived
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A Nutritional Intervention for Migraines
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