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Antioxidant

N-Acetyl Cysteine for Gulf War Syndrome (NAC Trial)

Phase < 1
Recruiting
Led By Nancy Klimas, MD
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on dialysis
47 to 70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 16 weeks
Awards & highlights

NAC Trial Summary

This trial will test if N-acetyl cysteine (NAC) can help reduce symptoms in Gulf War Illness (GWI) by reducing oxidative stress and boosting antioxidants.

Who is the study for?
This trial is for Gulf War veterans aged 47-70 who served between August 1990 and July 1991, meet the criteria for Gulf War Illness, and can consent to the study. They must not have severe mental health issues or substance abuse problems, no recent participation in other trials, and should not be on dialysis or have certain chronic infections.Check my eligibility
What is being tested?
The GWICTIC study is testing whether N-Acetyl Cysteine (NAC) can improve oxidative stress and antioxidant levels in those with Gulf War Syndrome compared to a placebo. It involves blood tests and neuroimaging to measure changes in serum glutathione concentration and brain oxidative stress.See study design
What are the potential side effects?
While specific side effects are not listed here, NAC may generally cause gastrointestinal discomfort like nausea or diarrhea, skin rash, headache, dizziness or fatigue. Side effects from placebos are usually minimal but can include similar symptoms due to psychological factors.

NAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently receiving dialysis.
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I am between 47 and 70 years old.
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I have not taken antiviral medications like interferon or ribavirin in the last 30 days.
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I have not taken any herbal medicine in the last 30 days.
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I am between 47 and 70 years old.

NAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess glutathione levels
Secondary outcome measures
Change in glutathione levels
Change in number of participants with treatment-related adverse events

NAC Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: N-Acetyl Cysteine (NAC)Active Control1 Intervention
Participants who are randomized to the intervention arm will receive N-Acetyl-L-Cysteine (Free-Form/NAC) 900mg two times a day for 8 weeks after the initiation of the first dose of study drug.
Group II: PlaceboPlacebo Group1 Intervention
Participants who are randomized to the placebo arm will take matching placebo two times a day for 8 weeks after the initiation of the first dose of study drug.

Find a Location

Who is running the clinical trial?

Boston UniversityOTHER
453 Previous Clinical Trials
9,941,529 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
260 Patients Enrolled for Gulf War Syndrome
Weill Medical College of Cornell UniversityOTHER
1,052 Previous Clinical Trials
1,330,102 Total Patients Enrolled
Nova Southeastern UniversityLead Sponsor
89 Previous Clinical Trials
11,473 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
160 Patients Enrolled for Gulf War Syndrome

Media Library

N-Acetyl Cysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT04987775 — Phase < 1
Gulf War Syndrome Research Study Groups: Placebo, N-Acetyl Cysteine (NAC)
Gulf War Syndrome Clinical Trial 2023: N-Acetyl Cysteine Highlights & Side Effects. Trial Name: NCT04987775 — Phase < 1
N-Acetyl Cysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987775 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are actively participating in this experimentation?

"Six medical sites are recruiting patients for this trial, including RTI International in Durham, Nova Southeastern University in Fort Lauderdale and VA New jersey Health Care System War Related Illness and Injury Study Center in East Orange. Additionally, three other facilities are also participating."

Answered by AI

What is the overarching objective of this medical experiment?

"The primary goal of the trial, which will span approximately 12 weeks, is to gauge glutathione levels. Secondary objectives include a review of treatment-related side effects based on safety questionnaires filled out at baseline and 8 week intervals; additionally, there is an assessment regarding the protection offered by intervention over time."

Answered by AI

How many participants are currently involved in this clinical research endeavor?

"At the current moment, no additional patients are being sought out for this trial. The original post date was October 1st 2022 and subsequent updates were made until August 1st 2022. If you're still interested in participating in medical trials, there exist 6 studies which require individuals with Gulf War Syndrome as well as 24 more involving N-Acetyl Cysteine (NAC)."

Answered by AI

Who is eligible to be involved in this research endeavor?

"This medical trial seeks 170 veterans of the Gulf War aged 47-70 to participate. Participants should have been present in the theatre between August 1990 and July 1991 and can possess comorbidities such as PTSD, MDD, or mTBI (severe TBI excluded). Furthermore, all volunteers must exhibit stable health indices throughout screening, give written consent for participation in follow up visits, and agree to allow normal illnesses associated with aging if they are being successfully treated prior to recruitment."

Answered by AI

Does the research study include geriatric participants?

"The age limitation for this trial are between 47 and 70 years old, as per the study's inclusion criteria."

Answered by AI

Are more participants being accepted for this trial at present?

"Regrettably, per the information on clinicaltrials.gov this research is no longer recruiting participants since it was initially posted in October of 2022 and last edited in August of 2022. Nevertheless, there are presently 30 other trials actively looking for individuals to join them."

Answered by AI

Could you elaborate on the research that has been conducted with N-Acetyl Cysteine (NAC)?

"N-Acetyl Cysteine (NAC) first appeared in the medical sphere at Suleyman Demirel University in 2013, and since then 18364 studies have been concluded. As of now, 24 active clinical trials are running; many taking place out of Durham, North carolina."

Answered by AI
~57 spots leftby Jun 2024