Gulf War Illness Inflammation Reduction Trial
Abstract
The objective of this study is to determine the underlying cause of Gulf War Illness (GWI) symptoms. Elevated blood biomarkers of inflammation were observed in our pilot observational study of GWI. Thus, we hypothesized that chronic inflammation is an underlying cause of GWI and reducing the inflammation may alleviate symptoms and improve the health-related quality of life. This is a randomized, two-group, double-blind, placebo-controlled clinical trial of modified-release prednisone (MR-prednisone) versus matching placebo. A total of 95 Gulf War Veterans were enrolled and 83 were randomized. MR-prednisone was chosen as the study drug because of its pleiotropic anti-inflammatory properties. The specific aims of the study are to measure the effects of the MR-prednisone versus placebo: 1) physical and mental functioning 2) pain, fatigue, and cognitive dysfunction 3) biomarkers of inflammation. All regulatory approvals for this clinical trial were received. The active phase of this study has been completed, and the data analysis phase is ongoing. 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 may be established. The potential impact of a successful study on the health and well-being of veterans with GWI is high.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2020
- Accession Number
- AD1113695
Entities
People
- Ronald R Bach
Organizations
- Minneapolis VA Medical Center