CompletedNot Applicable

Nutrition for Chronic Daily Headache

United States67 participantsStarted 2009-07

Plain-language summary

The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial comparing two potentially analgesic dietary interventions in patients with chronic daily headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on headache frequency and severity and 3) to assess the impact of the diet on the percentage of omega-6 highly unsaturated fatty acids (HUFA) in total HUFA in whole blood. During a 6-week baseline phase, eligible individuals with CDH will complete web-based daily diaries, self-report questionnaires, and nutrient intake assessments. Before randomization to one of the two intervention groups, blood will be collected to measure baseline nutritional biomarkers. Targeted dietary advice will be administered and foods will be provided throughout the 12-week intervention phase. Samples for biomarkers will be collected every 4 weeks during the intervention. Participants will continue recording headache characteristics with a daily headache diary. At the conclusion of the intervention, participants will provide complete follow-up assessments and blood for nutritional biomarker measurement.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age and older * either gender * meeting the 2004 International Classification of Headache Disorders (ICHD - II) criteria for the following forms of CDH (15 or more headache days per month and a headache history of more than two years with chronic migraine, transformed episodic migraine into CDH, chronic tension-type headache and new persistent daily headache) * under the care of a neurologist * willing and able to document headache characteristics and use of medications, as well as complete the assessment instruments * able to come in for 3 dietitian-administered dietary counseling sessions over 12 weeks * able to speak and understand English Exclusion Criteria: * analgesic rebound headache * hemicrania continua * drug-induced headache * post-traumatic headache * significant, symptomatic uncontrolled psychosis * undergoing current treatment for a major medical illness such as malignancy, autoimmune or immune deficiency disorder * pregnancy * clotting disorders * history of cranial or neck surgery within two years * vasculitis * chronic subdural hematoma * history of meningitis * history of subarachnoid or intracerebral hemorrhage * history of eating disorder * regular use of supplemental omega-3 fatty acids or gamma-linolenic acid

What they're measuring

Headache Impact Test

Timeframe: Pre-intervention and post-intervention

Trial details

NCT IDNCT01157208

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-11