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A Nutritional Intervention for Migraines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Physicians Committee for Responsible Medicine
ClinicalTrials.gov Identifier:
NCT01547494
First received: February 27, 2012
Last updated: May 13, 2013
Last verified: May 2013

February 27, 2012
May 13, 2013
September 2011
October 2012   (final data collection date for primary outcome measure)
  • Migraines Pain Change in Migraines frequency [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    Pain as measured by VAS score
  • Change in Migraines frequency [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
    the reduction in the number of migraine attacks.
Pain and Change in Migraines frequency [ Time Frame: change from baseline to 16 weeks ] [ Designated as safety issue: No ]
Pain as measured by VAS score and the reduction in the number of migraine attacks.
Complete list of historical versions of study NCT01547494 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: No ]
Health related quality of life as measured by a questionnaire
Quality of life [ Time Frame: change from baseline to 16 weeks ] [ Designated as safety issue: No ]
Health related quality of life as measured by a questionnaire
Not Provided
Not Provided
 
A Nutritional Intervention for Migraines
A Nutritional Intervention for Migraines

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Migraines
  • Other: Vegan Diet
    Vegan diet, which is devoid of animal products and minimal in fat
  • Dietary Supplement: mixture of omega3 and vitamins
    mixture of omega3 and vitamins
  • Placebo Comparator: Dietary Supplement
    Intervention: Other: Vegan Diet
  • Experimental: Vegan Diet
    Intervention: Dietary Supplement: mixture of omega3 and vitamins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01547494
WCCR-MIG1
Yes
Physicians Committee for Responsible Medicine
Physicians Committee for Responsible Medicine
Not Provided
Not Provided
Physicians Committee for Responsible Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP