Actively Recruiting
Mechanisms of Oxidative Stress During N-Acetyl Cysteine (NAC) Supplementation in Veterans With Gulf War Illness (GWI)
Led by Nova Southeastern University · Updated on 2025-07-08
170
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nova Southeastern University
Lead Sponsor
R
RTI International
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether N-Acetyl Cysteine (NAC) can reduce chronic oxidative stress and restore antioxidant levels in veterans with Gulf War Illness (GWI). This study focuses on understanding how NAC affects mitochondrial function and oxidative stress in the central nervous system (CNS), which are believed to contribute to the symptoms of GWI such as fatigue, pain, and neurological issues. The study is an early-phase, randomized, placebo-controlled trial aimed at exploring NAC's impact on serum glutathione levels and CNS oxidative stress. Participants will be randomly assigned to receive either NAC 900 mg twice daily or a matching placebo for 8 weeks. The intervention is designed to assess NAC's ability to target mitochondrial dysfunction and oxidative stress compared to placebo. The study includes a follow-up period extending to 16 weeks to monitor treatment-related adverse events and changes in glutathione levels. During the study, participants will undergo blood specimen collection and neuroimaging to measure glutathione levels and oxidative stress markers. Researchers will evaluate these markers from baseline through 8 weeks of treatment, with additional safety monitoring up to 16 weeks. Participants will be required to attend follow-up visits and provide written consent, with the total study duration covering the treatment and observation periods.
CONDITIONS
Brief Title
GWICTIC: NAC Mechanistic Study in Gulf War Veterans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 47 to 70 years
- Served in the Gulf War Theater between August 1990 and July 1991
- Meets modified Kansas case definition criteria for Gulf War Illness
- Allows stable, treated conditions like hypertension, diabetes, PTSD, major depressive disorder, and mild traumatic brain injury if stable
- Able to provide written consent
- Willing to participate in follow-up visits
You will not qualify if you...
- Current major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias, or CNS disorders affecting cognition
- Severe claustrophobia or difficulty with MRI (for MRS substudy only)
- Ferrous implanted medical devices or metal fragments under the skin (MRS substudy only)
- Heavy alcohol use exceeding 15 drinks per week or tobacco use exceeding 20 cigarettes per day
- Chronic active infections such as HIV, HBV, or HCV
- Renal disease with creatinine > 2.0 mg/dL
- Liver disease with bilirubin > 2.5 mg/dL or elevated transaminases
- Uncontrolled diabetes with HgbA1c > 7.5 without adequate care
- Diagnosed vascular disease including congestive heart failure
- Diagnosed bleeding disorders or use of blood thinners
- Recent use of certain antiviral medications or participation in other investigational trials
- Scheduled for surgery during study or recent surgery within 6 weeks
- Pregnant women
- Currently on dialysis
- Use of herbal medicine within 30 days prior to consent and screening blood draw
- Exclusionary diagnoses explaining fatigue symptoms and severity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take N-Acetyl Cysteine 900mg or matching placebo twice daily to help target oxidative stress and mitochondrial dysfunction related to Gulf War Illness.
Baseline visit and periodic follow-up visits during treatment
Duration - 8 weeks
Participants are monitored for treatment-related adverse events and changes in glutathione levels after completing the treatment period.
Periodic follow-up visits
Trial Site Locations
Total: 7 locations
1
VA Palo Alto Health Care System War Related Illness and Injury Study Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
Actively Recruiting
3
Boston University Medical School
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
4
VA New Jersey Health Care System War Related Illness and Injury Study Center
East Orange, New Jersey, United States, 07018
Actively Recruiting
5
Weill Cornell Medical College
New York, New York, United States, 10021
Active, Not Recruiting
6
RTI International
Durham, North Carolina, United States, 27709
Active, Not Recruiting
7
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nancy Klimas, MD
K
Karen Kesler, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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