Nutrition for Chronic Daily Headache
Completed · Not applicable
Conditions studied: Chronic Daily Headache
In brief
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.
Key facts
- Study ID
- NCT01157208
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 67
- Starts
- 2009-07-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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