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Gulf War Illness Inflammation Reduction Trial (GWIIRT)

Primary Purpose

Chronic Inflammation, Chronic Pain, Fatigue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Modified-Release Prednisone
Placebo
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammation focused on measuring Gulf War Illness, Chronic Inflammation, Modified-Release Prednisone, Health-Related Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Minneapolis Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified-Release Prednisone

Placebo

Arm Description

Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm

Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm

Outcomes

Primary Outcome Measures

Change from baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) scores at 8 and 16 weeks
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
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
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
CFQ asks questions about cognitive symptoms such as attention, concentration, and memory
Change from baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) scores at 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
Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses

Full Information

First Posted
July 20, 2015
Last Updated
April 7, 2022
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02506192
Brief Title
Gulf War Illness Inflammation Reduction Trial
Acronym
GWIIRT
Official Title
Gulf War Illness Inflammation Reduction Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
March 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammation, Chronic Pain, Fatigue, Cognitive Impairment
Keywords
Gulf War Illness, Chronic Inflammation, Modified-Release Prednisone, Health-Related Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blind, placebo-controlled
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified-Release Prednisone
Arm Type
Experimental
Arm Description
Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm
Intervention Type
Drug
Intervention Name(s)
Modified-Release Prednisone
Other Intervention Name(s)
Rayos
Intervention Description
Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill, inactive substance
Intervention Description
Placebo oral tablets (2x5mg) daily for 8 weeks
Primary Outcome Measure Information:
Title
Change from baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) scores at 8 and 16 weeks
Description
PCS is a measure of HRQOL with respect to physical functioning and symptoms.
Time Frame
0, 8, and 16 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of McGill Pain Questionnaire-short form (MPQ) scores at 8 and 16 weeks
Description
MPQ asks questions about sensory pain, affective pain, pain now, and typical pain
Time Frame
0, 8, and 16 weeks
Title
Change from baseline of Multidimensional Fatigue Inventory (MFI) scores at 8 and 16 weeks
Description
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Time Frame
0, 8, and 16 weeks
Title
Change from baseline of Cognitive Failures Questionnaire (CFQ) scores at 8 and 16 weeks
Description
CFQ asks questions about cognitive symptoms such as attention, concentration, and memory
Time Frame
0, 8, and 16 weeks
Title
Change from baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) scores at 8 and 16 weeks
Description
SF-36V MCS is a measure of HRQOL with respect to mental functioning
Time Frame
0, 8, and 16 weeks
Title
Change from baseline of Gulf War Illness-associated peripheral blood biomarkers
Description
Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses
Time Frame
0, 8, and 16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald R Bach, PhD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Veterans Affairs Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
After publication for as long as specified by the journal
IPD Sharing Access Criteria
Established investigators with legitimate scientific credentials

Learn more about this trial

Gulf War Illness Inflammation Reduction Trial

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