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

What Was Tested

The trial (phase 1, phase 2) is built around NAD+ for lupus (sle).

Study Description: Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyperresponsiveness.

Nicotinamide adenine dinucleotide (NAD)+ boosting with nicotinamide riboside blunts type 1 IFN activation in-vivo in monocytes of healthy subjects and ex-vivo in SLE subjects.

It had three arms (groups): Healthy controls (no intervention), Subjects with SLE - Active (active comparator) and Subjects with SLE - Placebo (placebo comparator).

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.

The registry classes the interventions as dietary supplement.

More on the Plan

Study Description: Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyper-responsiveness.

Who Took Part

78 planned participants were the target.

It was open to women only aged from 18 years up to 120 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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. Female subjects 18 years or older.

The full record lists 13 inclusion and 7 exclusion criteria; among the exclusions: 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; pregnancy or lactation (nursing).

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The lupus (sle) participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

The NAD+ group and the comparison group ran side by side rather than switching.

Neither the lupus (sle) participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-03-13 with completion listed for 2028-08-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The primary end point will be to assess the effect of NR on blunting type I IFN signaling and cytokine secretion from placebo vs. NR supplemented subjects in monocytes comparing baseline (visit 1 to visit 3) (time frame: 4 years).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 78 people with lupus (sle).

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Lupus (SLE) research.