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Gulf War Illness Inflammation Reduction Trial (GWIIRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02506192
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ronald Bach, Minneapolis Veterans Affairs Medical Center

Study Description
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Brief Summary:
The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.

Condition or disease Intervention/treatment Phase
Chronic Inflammation Chronic Pain Fatigue Cognitive Impairment Drug: Modified-Release Prednisone Drug: Placebo Phase 2

Detailed Description:
During Desert Shield and Desert Storm (Aug 2, 1990 to July 31,1991) 696,841 United States Military personnel were deployed to the Kuwaiti Theater of Operations. Today approximately one-third of those veterans are suffering from GWI, an unexplained chronic multi-symptom illness. Evidence of chronic inflammation in veterans with GWI has emerged from previous observational studies. The goal of this trial is to determine if reducing the GWI-associated chronic inflammation is an effective treatment for GWI. This is a randomized, two group, placebo controlled, double blind clinical trial. The treatment group will receive a low dose (2x5mg) once a day of delayed-release prednisone (Rayos) for 8 weeks. The placebo group will receive matching placebo (2x5mg) once a day for 8 weeks. The primary outcome measure for this clinical trial is a change from baseline of HRQOL with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of GWI-associated biomarkers of inflammation, changes from baseline of GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and a change from baseline of HRQOL with respect to mental functioning.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double-blind, placebo-controlled
Primary Purpose: Treatment
Official Title: Gulf War Illness Inflammation Reduction Trial
Study Start Date : July 2015
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : March 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified-Release Prednisone
Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm
 Drug: Modified-Release Prednisone
Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
Other Name: Rayos
Placebo Comparator: Placebo
Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm
 Drug: Placebo
Placebo oral tablets (2x5mg) daily for 8 weeks
Other Name: sugar pill, inactive substance


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
    PCS is a measure of HRQOL with respect to physical functioning and symptoms.


Secondary Outcome Measures :
  1. Change from baseline of McGill Pain Questionnaire-short form (MPQ) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
    MPQ asks questions about sensory pain, affective pain, pain now, and typical pain

  2. Change from baseline of Multidimensional Fatigue Inventory (MFI) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
    MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.

  3. Change from baseline of Cognitive Failures Questionnaire (CFQ) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
    CFQ asks questions about cognitive symptoms such as attention, concentration, and memory

  4. Change from baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
    SF-36V MCS is a measure of HRQOL with respect to mental functioning

  5. Change from baseline of Gulf War Illness-associated peripheral blood biomarkers [ Time Frame: 0, 8, and 16 weeks ]
    Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case Definition
  • Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2, 1990-July 31, 1991)

Exclusion Criteria:

  • Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD
  • Known hypersensitivity to Prednisone
  • Liver, (active or recent Hepatitis B or C treatment with a completion date within the past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6 months of treatment)
  • Treated Diabetes
  • Females who are Pregnant or Nursing
  • Female who refuses to use an accepted method of birth control
  • Exclusionary Labs: C-Reactive Protein >25, Creatinine Clearance <30, EFGR ≥ 30, Hgb A1-C >7, Glucose >120, WBC >12, RBC >6.2, Hematocrit >60, Hemoglobin <11, Platelets <100, Liver Function Tests (2 x the upper limit of AST and ALT, 2 x the upper limit of Total Bilirubin, and Alkaline Phosphatase)
  • Has Inflammatory Arthritis (RA, or Psoriatic Arthritis, Spondylitis, Polyarthritis)
  • Reactive Arthritis, or IBD associated Arthritis
  • Has any major inflammatory disease (acute Chronic Infections, Ulcerative Colitis, Crohn's Disease, Inflammatory lung diseases- COPD or Asthma requiring steroid treatment, Pericarditis, Vasculitis)
  • Has an chronic/active infection
  • Chronic use of Prednisone or Corticosteroids (occasional inhaled use of steroids acceptable)
  • Active Gum Disease or Dental Infection
  • Has been diagnosed with Lupus, Stroke, or Multiple Sclerosis. or any other diagnosis that produces symptoms of fatigue, cognitive impairment, or pain will be excluded based on the Kansas GWI Case definition
  • Has a condition that may interfere with the ability to accurately report symptoms, (Severe Psychiatric Problems, Schizophrenia, Bipolar Disorder, Alcohol or Drug Dependence requiring hospitalization, or regular illegal drug use)
  • Heart Disease (other than Hypertension), Heart Failure or Coronary Heart Disease requiring hospitalization within the past 12 months
  • Cancer (other than basal cell skin cancer), requiring treatment within the past 12 months, or life expectancy of less than 1 year.
  • Hospitalization within the past 3 months
Contacts and Locations
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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): NCT02506192


Locations
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United States, Minnesota
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
United States Department of Defense
Investigators
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Principal Investigator: Ronald R Bach, PhD Minneapolis Veterans Affairs Medical Center
More Information
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Responsible Party: Ronald Bach, Research Health Scientist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02506192    
Other Study ID Numbers: 4554-A
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication, all deidentified study data will be made available to other investigators upon request. Data sharing rule of the journal will apply.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After publication for as long as specified by the journal
Access Criteria: Established investigators with legitimate scientific credentials
Keywords provided by Ronald Bach, Minneapolis Veterans Affairs Medical Center:
Gulf War Illness
Chronic Inflammation
Modified-Release Prednisone
Health-Related Quality of Life
Additional relevant MeSH terms:
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Inflammation
Chronic Pain
Pathologic Processes
Pain
Neurologic Manifestations
Prednisone
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents