Evaluating the effects of NAD+ boosting on immunity in lupus patients

Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus

This study is testing if taking a supplement called nicotinamide riboside can help improve the immune system and reduce inflammation in women with lupus.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 120 Years
• Sex: Female
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: rituximab, belimumab, methotrexate, cyclophosphamide
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06032923 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of nicotinamide riboside (NR) supplementation on immunometabolism and inflammation in women with systemic lupus erythematosus (SLE). The study is designed as a double-blind, placebo-controlled intervention, focusing on how NR can modulate type I interferon signaling and improve endothelial function. Participants will be assessed for changes in immune cell behavior and metabolic profiles, with a primary endpoint measuring the secretion of interferon-beta in response to treatment. The trial aims to provide insights into potential therapeutic strategies for managing SLE.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older diagnosed with systemic lupus erythematosus and exhibiting mild to moderate disease activity.

Not a fit: Patients with severe disease activity or those on high doses of glucocorticoids or immunosuppressive drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of systemic lupus erythematosus by enhancing immune function and reducing inflammation.

How similar studies have performed: Previous studies have shown promising results with NAD+ boosting in other contexts, but this specific approach in SLE is novel.

Eligibility criteria

* 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Michael N Sack, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Rebecca D Huffstutler, C.R.N.P.

Conditions Systemic Lupus Erythematosus; Lupus; Chronic Inflammation