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Nutrition for Post-Traumatic Headache

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ClinicalTrials.gov Identifier: NCT03272399
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Fort Belvoir Community Hospital
Womack Army Medical Center
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kimbra Kenney, Uniformed Services University of the Health Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Chronic Without Intractable Headache Other: Diet/nutrition intervention Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeted Alteration in Omega-3 and Omega-6 Fatty Acids for Post-traumatic Headache (Nutrition for PTH)
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: H3-L6
High Omega-3, low Omega-6 diet
Other: Diet/nutrition intervention
The intervention will be administered through food products rather than dietary supplements
Other Name: High omega-3 versus high omega-6 dietary intervention

Active Comparator: L3-H6
Control diet containing average US polyunsaturated fatty acid (PUFA) content with low omega-3 and high omega-6 content
Other: Diet/nutrition intervention
The intervention will be administered through food products rather than dietary supplements
Other Name: High omega-3 versus high omega-6 dietary intervention




Primary Outcome Measures :
  1. Primary Clinical Outcome: 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 and improving headache-related quality of life. [ Time Frame: The HIT-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16 ]
    Up to 300 participants complete the Headache Impact Test (HIT-6)—a headache-specific quality of life measure 6 times while enrolled in the study. The primary outcome measure is the change in the HIT-6 scores at baseline and at the end of the diet intervention.

  2. Primary Biochemical Outcome: To evaluate the effects of the H3-L6 and L3-H6 Diet on circulating fatty acids and bioactive metabolites. [ Time Frame: Fasting blood draws at study visits at weeks 4, 10, 16 ]
    All study participants will have blood drawn 3 times during the 16-week study for analysis of circulating fatty acids and their bioactive metabolites. The following fatty acids will be measured in each blood sample (ng or pg per mL): 17-hydroxy-DHA (docosahexaenoic acid), 18-Hydroxy-EPA (eicosapentaenoic acid), 9-HODE (hydroxyl-octadecadienoic acid), 13-ODE (octadecadienoic acid), 5-HETE (hydroxyl-eicosatetraenoic acid), 8-HETE, 9-HETE, 11-HETE. Changes in 17-hydroxy-DHA and related fatty acids levels between blood draws at baseline and at the end of the 12-week diet intervention will be compared with changes in headache frequency and severity at the same time points.


Secondary Outcome Measures :
  1. 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. [ Time Frame: Daily on-line diary entry during the 16-week study ]
    Up to 300 participants complete a headache diary daily while enrolled in the 16-week study. Participants record the total number of headache hours per day. The outcome measure is the change in the mean daily headache hours at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

  2. To explore the potential of the H3-L6 intervention for improving non-headache pain outcomes. [ Time Frame: Study visits at week 0 and 16 ]
    Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in non-headache pain. A survey of pain, the Total Body Pain Scale, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in non-headache pain as measured by the survey at baseline and at the end of the diet intervention.

  3. To explore the potential of the H3-L6 intervention for decreasing acute pain medication usage [ Time Frame: Daily on-line diary entry during the 16-week study ]
    Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in: Use of acute pain medications. Participants will daily record all pain medications used in that 24-hour period. The outcome measure is the change in the acute pain medications sued at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

  4. To explore the potential of the H3-L6 intervention for improving sleep quality [ Time Frame: the PSQI is administered at weeks 4 and 16 of the study ]
    Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in sleep quality. A sleep quality survey, the PSQI, will be administered at baseline at and the end of the 12-week diet intervention. The outcome measure is the change in the PSQI score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

  5. To explore the potential of the H3-L6 intervention for improving psychological distress (depression/anxiety) [ Time Frame: Study visits at week 0 and 16 ]
    The PROMIS-29, a survey of psychological distress (depression/anxiety), will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in depression and/or anxiety as measured by the PROMIS-29 at baseline and at the end of the diet intervention.

  6. To explore the potential of the H3-L6 intervention for improving symptoms of post-traumatic stress disorder (PTSD) [ Time Frame: The PCL-C is administered at study visits at weeks 4 &16 ]
    Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in symptoms of post-traumatic stress disorder (PTSD). The PCL-C, a survey of post-traumatic stress symptoms, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is the reduction in the PCL-C score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.

  7. To explore the potential of the H3-L6 intervention for improving post-concussive symptoms. [ Time Frame: NSI and GOS-E are administered at weeks 4 and 16. ]
    Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in post-concussive symptoms. The Neurobehavioral Symptom Inventory (NSI) and the Glasgow Outcome Score-Extended (GOS-E) will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a change in the NSI and GOS-E score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In order to be included in the study, you must be a person of either gender who is at least 18 years of age, meets criteria of having had a traumatic brain injury, a physiological disruption of brain function, as manifested by at least one of the following:

    1. . Any period of loss of consciousness
    2. . Any loss of memory for events immediately before or after the accident
    3. . Any alteration of mental state at the time of the accident (e.g., feeling dazed, disoriented, and confused)
    4. . Focal neurologic deficits that may or may not be permanent.

      • Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (i.e. whiplash) without direct external trauma to the head.
  • Meets Internation Classification of Headache Disorders-version III (ICHD-III) criteria for persistent post-traumatic headache which is defined as a headache of at least 3 months duration caused by a traumatic injury to the head.
  • Meets ICHD-III criteria for episodic/chronic migraine, with or without aura (excepting exclusion for organic disease):

    1. . Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
    2. . Headache has at least 2 of the following characteristics:

      1. unilateral location
      2. pulsating quality
      3. moderate or severe pain intensity
      4. aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
    3. . During headache at least 1 of the following:

      1. nausea and/or vomiting
      2. photophobia and phonophobia
  • A potential candidate for this study must be under the care of a physician for headaches and have an incomplete response to standard headache treatments.
  • Must have headache frequency of more than 8 days per month.
  • Must have a headache history of more than 6 months
  • Must be able to attend or remotely participate (by video conference or telephone) in seven dietitian counseling sessions, and adhere to diet supplied to study participants.
  • Must be a Department of Defense (DoD) healthcare beneficiary and eligible to receive care at Walter Reed National Military Medical Center (WRNMMC), Fort Belvoir Community Hospital (FBCH) or Womack Army Medical Center (WAMC).

Exclusion Criteria:

  • A person cannot be in this study if they have a history of specific food allergies, especially to fish, dairy or gluten.

Also exclusionary are:

  • Pregnancy or anticipated pregnancy
  • Aversion to eating fish
  • History of organic brain disorder other than TBI (vasculitis, encephalitis, meningitis, brain tumor)
  • Major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorders, history of stroke or myocardial infarction
  • Anticipated deployment or move to alternate location in the next 16 weeks
  • Inability to read and communicate in English
  • Regular use of fatty acid containing supplements
  • Active or recent (2 years) history of treatment for substance abuse
  • Cognitive impairment that prevents understanding of the protocol and completion of study procedures including compliance with the diet, blood draws and maintaining a daily headache diary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272399


Contacts
Contact: Kimbra Kenney, MD 301 400 0492 kimbra.kenney@usuhs.edu
Contact: Carol Moore, MS carol.moore.ctr@usuhs.edu

Locations
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Contact: Cora Davis    301-319-3780    cora.davis.ctr@usuhs.edu   
Contact: Kimbra Kenney, MD    301 400 0942    kimbra.kenney@usuhs.edu   
United States, North Carolina
Womack Army Medical Center (WAMC) Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Jacques Arrieux    910-908-2268    jacques.p.arrieux.ctr@mail.mil   
Contact: Katie Russell    910 908 2274    katie.n.russell.ctr@mail.mil   
United States, Virginia
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Rebecca Sandlain       rebecca.l.sandlain.ctr@mail.mil   
Contact: Melissa Guerra, MD       melissa.f.guerra.civ@mail.mil   
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Fort Belvoir Community Hospital
Womack Army Medical Center
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kimbra Kenney, MD Uniformed Services University of the Health Sciences
Study Director: Chris Ramsden, MD National Institutes of Health (NIH)
Study Director: John Mann, MD UNC

Additional Information:
Publications:
Responsible Party: Kimbra Kenney, Associate Professor, Neurology, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT03272399     History of Changes
Other Study ID Numbers: 416047
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study data to be uploaded into Federation Interagency Traumatic Brain Injury Repository (FITBIR) and made accessible after study is completed
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After study is uploaded into FITBIR
Access Criteria: Through FITBIR

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Headache
Post-Traumatic Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Brain Diseases
Central Nervous System Diseases