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NCT03272399

Nutrition for Post-Traumatic Headache

Status unknown Phase 2 Last updated 5 October 2021
What this trial tests

Phase 2 trial testing Diet/nutrition intervention in Post-Traumatic Headache Chronic Without Intractable Headache in 300 participants. Status unknown.

Timeline
21 August 2017
Primary endpoint
31 March 2022
31 March 2022

Quick facts

Lead sponsorUniformed Services University of the Health Sciences
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment300
Start date21 August 2017
Primary completion31 March 2022
Estimated completion31 March 2022
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Uniformed Services University of the Health Sciences

Who can join

18 and older, any sex, with Post-Traumatic Headache Chronic Without Intractable Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Identifying oxidized lipid mediators as prognostic biomarkers of chronic posttraumatic headache.
    Domenichiello AF, Jensen JR, Zamora D, Horowitz M, et al · · 2020 · cited 14× · PMID 32694380 · DOI 10.1097/j.pain.0000000000001983
  2. Targeted dietary interventions to reduce pain in persistent post-traumatic headache among service members: Protocol for a randomized, controlled parallel-group trial.
    Faurot KR, Cole WR, MacIntosh BA, Dunlap M, et al · · 2022 · cited 4× · PMID 35842107 · DOI 10.1016/j.cct.2022.106851
  3. A High Omega-3, Low Omega-6 Diet Reduces Headache Frequency and Intensity in Persistent Post-Traumatic Headache: A Randomized Trial.
    Zamora D, Kenney K, Horowitz M, Cole WR, et al · · 2025 · cited 2× · PMID 40600308 · DOI 10.1089/neu.2025.0126
  4. Biochemical and behavioral effects of decreasing dietary linoleic acid and increasing eicosapentaenoic acid and docosahexaenoic acid in a rat chronic monoarthrits model.
    Domenichiello AF, Wilhite BC, Nara P, Pitcher MH, et al · · 2022 · cited 2× · PMID 36347090 · DOI 10.1016/j.plefa.2022.102512

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