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Gulf War Illness Inflammation Reduction Trial

NCT ID: NCT02506192

Last Updated: 2024-12-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2023-10-19

Brief Summary

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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

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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.

Conditions

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Chronic Inflammation Chronic Pain Fatigue Cognitive Impairment

Keywords

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Gulf War Illness Chronic Inflammation Modified-Release Prednisone Health-Related Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
double-blind, placebo-controlled

Study Groups

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Modified-Release Prednisone

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

Group Type EXPERIMENTAL

Modified-Release Prednisone

Intervention Type DRUG

Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral tablets (2x5mg) daily for 8 weeks

Interventions

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Modified-Release Prednisone

Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks

Intervention Type DRUG

Placebo

Placebo oral tablets (2x5mg) daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Rayos sugar pill, inactive substance

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Ronald Bach

Research Health Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald R Bach, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

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Minneapolis Veterans Affairs Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 37319244 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0286817

link to citation

Other Identifiers

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4554-A

Identifier Type: -

Identifier Source: org_study_id