Gulf War Illness Inflammation Reduction Trial
Condition: Chronic Inflammation; Chronic Pain; Fatigue; Cognitive Impairment
MeSH terms: Inflammation; Chronic Pain
Intervention: Modified-Release Prednisone; Placebo
Intervention description: Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks; Placebo oral tablets (2x5mg) daily for 8 weeks
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: double-blind, placebo-controlled
Enrollment: 83.0
Sex: All
Healthy volunteers: No
Keywords: Gulf War Illness; Chronic Inflammation; Modified-Release Prednisone; Health-Related Quality of Life

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.
    

Eligibility 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