Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-26 @ 3:53 PM
Study NCT ID:
NCT01547494
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2012-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutritional Intervention for Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-13', 'studyFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraines Pain Change in Migraines frequency', 'timeFrame': 'Baseline and 4 months', 'description': 'Pain as measured by VAS score'}, {'measure': 'Change in Migraines frequency', 'timeFrame': 'Baseline and 4 months', 'description': 'the reduction in the number of migraine attacks.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Baseline and 4 months', 'description': 'Health related quality of life as measured by a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Migraines', 'Diet, Vegetarian', 'Diet, Fat-Restricted', 'Pain'], 'conditions': ['Migraines']}, 'referencesModule': {'references': [{'pmid': '25339342', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders18\n\n * At least 5 attacks fulfilling criteria the criteria below\n * Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)\n * Headache has at least two of the following characteristics:\n\n * unilateral location\n * pulsating quality\n * moderate or severe pain intensity\n * aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)\n * During headache at least one of the following:\n\n * nausea and/or vomiting\n * photophobia and phonophobia\n * Not attributed to another disorder\n2. Migraines occurring at least twice per month, on average.\n3. Age at least 18 years\n4. Ability and willingness to participate in all components of the study\n5. Willingness to be assigned to either the diet group or supplement group\n6. Migraine medications unchanged within last 6 weeks.\n\nExclusion Criteria:\n\n1. \\< 18 years of age\n2. 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\n3. Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)\n4. Pregnancy\n5. Unstable medical or psychiatric illness\n6. Likely to be disruptive in group sessions (as determined by research staff)\n7. Already following a low-fat, vegan diet\n8. Lack of English fluency\n9. Inability to maintain current medication regimen\n10. Inability or unwillingness to participate in all components of the study'}, 'identificationModule': {'nctId': 'NCT01547494', 'briefTitle': 'A Nutritional Intervention for Migraines', 'organization': {'class': 'OTHER', 'fullName': 'Physicians Committee for Responsible Medicine'}, 'officialTitle': 'A Nutritional Intervention for Migraines', 'orgStudyIdInfo': {'id': 'WCCR-MIG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dietary Supplement', 'interventionNames': ['Other: Vegan Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Vegan Diet', 'interventionNames': ['Dietary Supplement: mixture of omega3 and vitamins']}], 'interventions': [{'name': 'Vegan Diet', 'type': 'OTHER', 'description': 'Vegan diet, which is devoid of animal products and minimal in fat', 'armGroupLabels': ['Dietary Supplement']}, {'name': 'mixture of omega3 and vitamins', 'type': 'DIETARY_SUPPLEMENT', 'description': 'mixture of omega3 and vitamins', 'armGroupLabels': ['Vegan Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Physicians Committee for Responsible Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Physicians Committee for Responsible Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}