Gulf War Illness Inflammation Reduction Trial
Technical Report,29 Sep 2015,28 Sep 2016
Minneapolis VA Medical Center Minneapolis United States
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The objective of this clinical trial is to find an evidence-based treatment for Gulf War Illness GWI. Elevated biomarkers of inflammation were observed in our pilot observational study of GWI. Thus, chronic inflammation appears to be part of the underlying pathophysiology of GWI. Reducing GWI-associated inflammation may alleviate some symptom of the disorder and improve the health-related quality of life of veterans with GWI. This is a randomized, two-group, double-blind, placebo-controlled clinical trial of delayed-release prednisone versus matching placebo. A total of 100 veterans with GWI will be enrolled in the trial. Prednisone was chosen as the study drug because of its well-established pleiotropic anti-inflammatory properties. The specific aims of the study are to measure the effects of the treatment on the following 1 physical and mental functioning 2 pain, fatigue, and cognitive dysfunction 3 biomarkers of inflammation. All regulatory approvals for this clinical trial have been received. Recruitment and enrollment have begun. A successful trial with improved clinical outcomes and reduced proinflammatory biomarkers would be direct evidence of the role that chronic inflammation plays in the underlying pathophysiology of GWI. Thus, a new paradigm for the diagnosis and treatment of GWI would be established. The potential impact of this new paradigm on the health and well-being of veterans with GWI is very significant.
- Medicine and Medical Research