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Nutrition for Post-Traumatic Headache

NCT03272399 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-10-05

No results posted yet for this study

Summary

The purpose of this multi-site study is to evaluate the efficacy of a high omega-3/low omega-6 dietary intervention (the H3-L6 Diet) vs. a Control Diet in reducing headache pain and improving function in soldiers, veterans and military healthcare beneficiaries with post-traumatic headache (PTH). In addition, the study will examine the effects of the diet interventions on anti-nociceptive and pro-nociceptive lipid mediators derived from omega-3 and omega-6 fatty acids.

Conditions

  • Post-Traumatic Headache Chronic Without Intractable Headache

Interventions

OTHER

Diet/nutrition intervention

The intervention will be administered through food products rather than dietary supplements

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • Fort Belvoir Community Hospital

    collaborator FED

  • Womack Army Medical Center

    collaborator FED

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Uniformed Services University of the Health Sciences

    lead FED

Principal Investigators

  • Kimbra Kenney, MD · Uniformed Services University of the Health Sciences

  • Chris Ramsden, MD · National Institutes of Health (NIH)

  • John Mann, MD · UNC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272399 on ClinicalTrials.gov