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Gulf War Illness Inflammation Reduction Trial (GWIIRT)

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ClinicalTrials.gov Identifier: NCT02506192
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ronald Bach, Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE July 20, 2015
First Posted Date  ICMJE July 23, 2015
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
Change from baseline of Veterans Short Form 36-Item Health Survey Physical Component Summary (SF-36V PCS) scores at 8 and 16 weeks [ Time Frame: 0, 8, and 16 weeks ]
SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02506192 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
  • 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
  • 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.
  • 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
  • Change from baseline of Veterans Short Form 36-Item Health Survey Mental Component Summary (SF-36V 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gulf War Illness Inflammation Reduction Trial
Official Title  ICMJE Gulf War Illness Inflammation Reduction Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Inflammation
  • Chronic Pain
  • Fatigue
  • Cognitive Impairment
Intervention  ICMJE
  • Drug: Delayed-Release Prednisone
    Delayed-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
    Other Name: Rayos
  • Drug: Placebo
    Placebo oral tablets (2x5mg) daily for 8 weeks
    Other Name: sugar pill, inactive substance
Study Arms  ICMJE
  • Experimental: Delayed-Release Prednisone
    Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm
    Intervention: Drug: Delayed-Release Prednisone
  • Placebo Comparator: Placebo
    Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Rudquist 612-467-6351 rebecca.rudquist@va.gov
Contact: Susan Johnson 612-629-7492 susan.johnson4@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02506192
Other Study ID Numbers  ICMJE 4554-A
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ronald Bach, Minneapolis Veterans Affairs Medical Center
Study Sponsor  ICMJE Minneapolis Veterans Affairs Medical Center
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Ronald Bach, PhD Minneapolis Veterans Affairs Medical Center
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP