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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

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

Study contacts

• Principal investigator: Rachael J Klein, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Rebecca D Huffstutler, C.R.N.P.
• Email: rebecca.huffstutler@nih.gov
• Phone: (301) 594-1281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Extension of enpatoran for cutaneous lupus symptoms

  This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.

  Recruiting Phase 3 EMD Serono · Troy, Michigan · NCT07840287

• Targeting B cells and plasma cells in lupus with a dual-action antibody

  A new injectable therapy (F182112) will be tested in adults with systemic lupus erythematosus to see if it can help by hitting both CD3 on immune cells and BCMA on B cells and plasma cells.

  Recruiting Phase 1 Shandong New Time Pharmaceutical Co., LTD · Shanghai · NCT07829614

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Carotid ultrasound to guide prevention of heart disease in inflammatory rheumatic diseases

  In people with inflammatory rheumatic diseases like RA, PsA, AxSpA, or SLE who are at modest cardiovascular risk, a carotid ultrasound test is used to see if they should start stronger lipid-lowering therapy to prevent heart problems.

  Recruiting at 7 sites Phase 4 Instituto de Investigación Marqués de Valdecilla · Alicante, Alicante and 16 other locations · NCT07611747

• Periodontal Health in Rare Kidney Conditions and Controls

  This study tests how common periodontitis is in people with rare kidney disorders and compares it to CKD patients and people without kidney disease.

  Recruiting Institutul Clinic Fundeni · Bucharest · NCT07575347

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.