Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (Sle)
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus (Sle) focused on measuring Lupus, Chronic Inflammation
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) more than or equal to 2 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; 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. Control subjects: Female subjects 18 years or older No history of autoimmune or inflammatory disease; 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 Current treatment with specific immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus); Treatment with cyclophosphamide or IVIG within the 6 months prior to screening and or increase in glucocorticoid dose within 4 weeks of screening; Dietary vitamin B3 or tryptophan supplementation within 6 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 Dietary vitamin B3 or tryptophan supplementation within 6 weeks 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.
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Active Comparator
Placebo Comparator
Healthy controls
Subjects with SLE - Active
Subjects with SLE - Placebo
This group will not receive the dietary supplement or placebo.
This study group will take the dietary supplement Nicotinamide Riboside capsules.
This study group will take the Placebo.