Lupus trial tests NAD+ booster to tame immune system
NCT ID NCT06032923
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 9 times
Summary
This study tests whether a supplement called nicotinamide riboside (NR) can reduce inflammation and improve immune cell function in women with mild-to-moderate lupus. About 78 participants will receive either NR or a placebo for 12 weeks. Researchers will measure changes in immune signaling and blood vessel health to see if NR helps control the disease.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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 to 120 years
- Sex
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Female participants only
- 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.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: SLE subjects: * Female subjects 18 years or older who meets \> 3 of 11 modified Am. Coll. of Rheumatology (ACR) (1997) Revised Criteria for SLE and mild/moderate disease activity defined as an SLE Disease Activity Index 2000(SLEDAI 2K) between zero and less than or equal to 14 at screening; * If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stable for at least 4 weeks prior to screening; * If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, dose must have been stable for the 12 weeks prior to screening. The max. allowed doses - hydroxychloroquine 400 mg/day, chloroquine phosphate 500 mg/day and quinacrine 100 mg/day; * If on immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus); dose must have been stable for the 12 weeks prior to screening * Subjects of childbearing potential must agree to practice effective birth control for the duration of the study; * Stated willingness to comply with all study procedures and availability for the duration of the study; * Agreement to adhere to Lifestyle Considerations throughout study duration; * Ability of subject to understand and the willingness to sign a written informed consent document. * If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the baseline visit. Control subjects: * Female subjects 18 years or older * No history of autoimmune or inflammatory disease * If on vitamin B3 or tryptophan supplementation at screening, willing to stop it at least 6 weeks before the blood draw visit. EXCLUSION CRITERIA: SLE Subjects: * Active renal or central nervous system disease or major renal or hepatic dysfunction; * Treatment with rituximab, belimumab or any other biologic agent within the 6 months prior to screening * Treatment with cyclophosphamide or IVIG within the 6 months prior to screening and or increase in glucocorticoid dose within 4 weeks of screening; * Pregnancy or lactation (nursing) * Treatment with another investigational drug or other intervention within 6 months of screening Control Subjects: * Inability to sign consent * Pregnancy or nursing Pregnant women are excluded from participation on this study. Self-reported pregnancy status may be accepted from female control participants of child-bearing potential for a blood draw which is considered a minimal risk procedure.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody aims to wipe out Lupus-Causing immune cells
- Can a single cell therapy calm multiple autoimmune diseases?
- Can a Three-Drug combo quiet lupus kidney flares?
- Can a new antibody tame lupus flares?
- Can a single infusion of reprogrammed immune cells quiet lupus kidney disease?
- Eye tests could spot silent vision damage in lupus patients