NCT02506192

Gulf War Illness Inflammation Reduction Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammation
• Chronic Pain
• Fatigue
• Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Modified-Release Prednisone	Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
DRUG	Placebo	Placebo oral tablets (2x5mg) daily for 8 weeks

Timeline

• Start date: 2015-07-01
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2015-07-23
• Last updated: 2024-12-10
• Results posted: 2023-12-06

Locations

1 site across 1 country: United States