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Could a common supplement ease lupus?
NCT ID NCT00775476
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether N-acetylcysteine (NAC), an antioxidant supplement, can help people with systemic lupus erythematosus (SLE). About 290 participants will first take NAC for 3 months to find a tolerable dose, then be randomly assigned to continue NAC or switch to a placebo for another 10 months. The goal is to see if NAC improves lupus symptoms and reduces the need for steroids, while monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- N-acetylcysteine (NAC)
- What this could lead to
- If it works, this could offer a safer, more targeted treatment option for lupus, potentially reducing reliance on steroids and other harsh medications.
- What could go wrong
- This is a phase 2 trial, so results are still early and may not confirm benefit. NAC may cause side effects like nausea or allergic reactions, and the placebo group helps check if any improvement is real.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Participant Inclusion Criteria * Age ≥ 18; * Male or female; * ≥ 4 ACR SLE classification criteria (104,105); * Positive ANA at a titer of ≥ 1/80; * Stable immunosuppressants (MMF ≤ 3 g/day, azathioprine ≤ 150 mg/day; methotrexate ≤ 25 mg/week; leflunomide ≤ 20 mg/week; cyclosporin 100 mg/day; voclosporin 47.4 mg/day) and/or antimalarials (hydroxychloroquine ≤ 400 mg/day) for 30 days prior to screening; stable oral corticosteroids for 2 weeks prior to screening; ≤ 20 mg/day prednisone or equivalent; stable belimumab or anifrolumab for 90 days prior to screening; * Untreated patients must be off above immunosuppressants and/or antimalarials for 30 days prior to screening; oral corticosteroids for 2 weeks prior to screening; belimumab or anifrolumab for 90 days prior to screening; * BILAG 2004 index (48) level A disease activity in ≥ 1 organ/system except renal or central nervous system or BILAG 2004 index level B disease activity in ≥ 1 organs/systems if no level A disease activity is present and SLEDAI ≥ 6 (106); * Enrollment is approved by adjudication committee within 10 days, which may include retesting and communication with study sites, as necessary. * Patients may be considered for enrollment 12 months after rituximab treatment, or 6 months after rituximab treatment if their B cell counts have normalized. Participant Exclusion Criteria * Acute SLE flare threatening vital organs; * Pregnant or lactating; * Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events; * Patients receiving cyclophosphamide within 3 months; * Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients with oral steroid-dependent asthma; * Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening; Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening (which is considered sufficient time to revert GSH to pre-treatment levels (29); * Patients who participated in the pilot RCT or are taking daily acetaminophen (≤ 1 g/day prn is allowed if documented); * Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus); * Patients enrolled in other interventional trials. * Patients should not take medications containing acetaminophen (Tylenol) as it may reduce the effectiveness of NAC. 1 g/day of acetaminophen is allowed if documented. Patients who are currently taking more than 1 gram of acetaminophen per day may be eligible for participation if they are willing to reduce their intake to 1 gram per day or less prior to enrollment. * Patients should avoid taking more than 500 mg of vitamin C and more than 30 IU of vitamin E daily as both vitamin C and E can confound the study results. However, patients currently taking doses above these thresholds may be eligible for participation if they are willing to reduce their intake to 500 mg or less of vitamin C and 30 IU or less of vitamin E per day prior to enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Emory University School of Medicine
Atlanta, Georgia, 30307, United States
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Hospital for Special Surgery
New York, New York, 10021, United States
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Penn State MS Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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SUNY Upstate Medical University
Syracuse, New York, 13210, United States
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St. Luke's University Health Network
Allentown, Pennsylvania, 18102, United States
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The Ohio State University
Columbus, Ohio, 43210, United States
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University of Columbia
New York, New York, 10032, United States
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University of Kentucky
Lexington, Kentucky, 40536, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
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VA Medical Center
Oklahoma City, Oklahoma, 73104, United States
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Yale Center for Clinical Investigation
New Haven, Connecticut, 06519, United States
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