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Gulf War Illness Inflammation Reduction Trial (GWIIRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Ronald Bach, Minneapolis Veterans Affairs Medical Center
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ronald Bach, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT02506192
First received: July 20, 2015
Last updated: September 13, 2016
Last verified: September 2016
  Purpose
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 Intervention Phase
Chronic Inflammation
Chronic Pain
Fatigue
Cognitive Impairment
Drug: Delayed-Release Prednisone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gulf War Illness Inflammation Reduction Trial

Resource links provided by NLM:


Further study details as provided by Ronald Bach, Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: July 2015
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delayed-Release Prednisone
Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm
Drug: Delayed-Release Prednisone
Delayed-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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02506192

Contacts
Contact: Rebecca Rudquist 612-467-6351 rebecca.rudquist@va.gov
Contact: Susan Johnson 612-629-7492 susan.johnson4@va.gov

Locations
United States, Minnesota
Minneapolis Veterans Affairs Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Rebecca R Rudquist    612-467-6351    rebecca.rudquist@va.gov   
Contact: Susan Johnson    612-629-7492    susan.johnson4@va.gov   
Principal Investigator: Ronald Bach, PhD         
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
United States Department of Defense
Investigators
Principal Investigator: Ronald Bach, PhD Minneapolis Veterans Affairs Medical Center
  More Information

Responsible Party: Ronald Bach, Research Health Scientist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02506192     History of Changes
Other Study ID Numbers: 4554-A
Study First Received: July 20, 2015
Last Updated: September 13, 2016

Keywords provided by Ronald Bach, Minneapolis Veterans Affairs Medical Center:
Gulf War Illness
Chronic Inflammation
Delayed-Release Prednisone
Health-Related Quality of Life

Additional relevant MeSH terms:
Inflammation
Fatigue
Chronic Pain
Cognition Disorders
Pathologic Processes
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 25, 2017