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Diet/nutrition intervention for Post-Traumatic Headache
Phase 2
Waitlist Available
Led By Kimbra Kenney, MD
Research Sponsored by Uniformed Services University of the Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the hit-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16
Awards & highlights
Study Summary
This trial will study whether a diet high in omega-3/low in omega-6 can reduce headache pain and improve function in people with post-traumatic headaches.
Eligible Conditions
- Post-Traumatic Headache
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the hit-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the hit-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Biochemical Outcome: To evaluate the effects of the H3-L6 and L3-H6 Diet on circulating fatty acids and bioactive metabolites.
Omega-3 fatty acids
Secondary outcome measures
To compare the efficacy of the high omega-3/low omega-6 (H3-L6) diet to the low omega-3/high omega-6 (L3-H6) diet in reducing headache pain.
To explore the potential of the H3-L6 intervention for decreasing acute pain medication usage
To explore the potential of the H3-L6 intervention for improving non-headache pain outcomes.
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: H3-L6Experimental Treatment1 Intervention
High Omega-3, low Omega-6 diet
Group II: L3-H6Active Control1 Intervention
Control diet containing average US polyunsaturated fatty acid (PUFA) content with low omega-3 and high omega-6 content
Find a Location
Who is running the clinical trial?
Uniformed Services University of the Health SciencesLead Sponsor
116 Previous Clinical Trials
91,116 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,197 Total Patients Enrolled
3 Trials studying Post-Traumatic Headache
559 Patients Enrolled for Post-Traumatic Headache
Fort Belvoir Community HospitalFED
13 Previous Clinical Trials
1,956 Total Patients Enrolled
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