Gulf War Illness Inflammation Reduction Trial
GWIIRT
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2023
CompletedResults Posted
Study results publicly available
December 6, 2023
CompletedDecember 10, 2024
November 1, 2024
8.3 years
July 20, 2015
October 19, 2023
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks
The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status,
0, 8, and 16 weeks
Secondary Outcomes (5)
Change From Baseline of McGill Pain Questionnaire-short Form (MPQ) Scores at 8 and 16 Weeks
0, 8, and 16 weeks
Change From Baseline of Multidimensional Fatigue Inventory (MFI) Scores at 8 and 16 Weeks
0, 8, and 16 weeks
Change From Baseline of Cognitive Failures Questionnaire (CFQ) Scores at 8 and 16 Weeks
0, 8, and 16 weeks
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks
0, 8, and 16 weeks
Change From Baseline of Gulf War Illness-associated Peripheral Blood Biomarkers
0, 8, and 16 weeks
Study Arms (2)
Modified-Release Prednisone
EXPERIMENTALTake oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm
Placebo
PLACEBO COMPARATORTake oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm
Interventions
Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
Placebo oral tablets (2x5mg) daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, 55417, United States
Related Publications (1)
Bach RR, Rudquist RR. Gulf war illness inflammation reduction trial: A phase 2 randomized controlled trial of low-dose prednisone chronotherapy, effects on health-related quality of life. PLoS One. 2023 Jun 15;18(6):e0286817. doi: 10.1371/journal.pone.0286817. eCollection 2023.
PMID: 37319244BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ronald R Bach, PhD, Principal Investigator
- Organization
- Minneapolis VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald R Bach, PhD
Minneapolis Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double-blind, placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Health Scientist
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 23, 2015
Study Start
July 1, 2015
Primary Completion
October 19, 2023
Study Completion
October 19, 2023
Last Updated
December 10, 2024
Results First Posted
December 6, 2023
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication for as long as specified by the journal
- Access Criteria
- Established investigators with legitimate scientific credentials
After publication, all deidentified study data will be made available to other investigators upon request. Data sharing rule of the journal will apply.