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Double-blind Placebo Controlled Study to Evaluate the Effect of NAD+ Boosting With Nicotinamide Riboside on Immunometabolism and Immunity in Systemic Lupus Erythematosus
Minor13 versionsRe-verified since Sep 7, 2024, no change to tracked fieldsv121-v133
MinorEligibility criteria shortened, about 10 wordsv120
MinorEligibility criteria expanded, about 33 wordsv119
Minor6 versionsRe-verified since Mar 30, 2024, no change to tracked fieldsv113-v118
MinorEligibility criteria expanded, about 6 wordsv112
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MinorStart date changed from estimate of Mar 20, 2024 to Mar 13, 2024v111
MinorStart date: Mar 18, 2024 to Mar 20, 2024v110
MinorStart date: Mar 17, 2024 to Mar 18, 2024v109
MinorStart date: Mar 14, 2024 to Mar 17, 2024v108
MinorStart date: Mar 13, 2024 to Mar 14, 2024v107
MinorStart date: Mar 12, 2024 to Mar 13, 2024v106
MinorStart date: Mar 11, 2024 to Mar 12, 2024v105
MinorStart date: Mar 10, 2024 to Mar 11, 2024v104
MinorStart date: Mar 7, 2024 to Mar 10, 2024v103
MinorStart date: Mar 6, 2024 to Mar 7, 2024v102
MinorStart date: Mar 5, 2024 to Mar 6, 2024v101
MinorStart date: Mar 4, 2024 to Mar 5, 2024v100
MinorStart date: Feb 29, 2024 to Mar 4, 2024v99
MinorStart date: Feb 28, 2024 to Feb 29, 2024v98
MinorStart date: Feb 27, 2024 to Feb 28, 2024v97
MinorStart date: Feb 26, 2024 to Feb 27, 2024v96
MinorStart date: Feb 25, 2024 to Feb 26, 2024v95
MinorStart date: Feb 22, 2024 to Feb 25, 2024v94
MinorStart date: Feb 20, 2024 to Feb 22, 2024v93
MinorStart date: Feb 19, 2024 to Feb 20, 2024v92
MinorStart date: Feb 18, 2024 to Feb 19, 2024v91
MinorStart date: Feb 15, 2024 to Feb 18, 2024v90
MinorStart date: Feb 14, 2024 to Feb 15, 2024v89
NotableTrial status: Not Yet Recruiting to Recruiting
Start date: Feb 12, 2024 to Feb 14, 2024
Site details revised
v88
MinorStart date: Feb 11, 2024 to Feb 12, 2024v87
MinorStart date: Feb 7, 2024 to Feb 11, 2024v86
MinorStart date: Feb 6, 2024 to Feb 7, 2024v85
MinorStart date: Feb 5, 2024 to Feb 6, 2024v84
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Study Description:
Systemic lupus erythematosus (SLE) occurs predominantly in women and is driven by type I interferon dysregulation and neutrophil hyperresponsiveness. Neutrophils in females have reduced mitochondrial bioenergetic capacity which affects immunometabolism. 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. These findings support the proposal of the hypothesis that NAD+ boosting by NR supplementation will modulate metabolic pathways in lupus and blunt type 1 interferon signaling. Moreover, as type 1 interferon drives endothelial dysfunction, linked to increased cardiovascular risk, the effect of NR on endothelial function will be examined.
Objectives:
Primary Objective: Evaluate the effect of NR vs. placebo on immunometabolic and inflammatory remodeling in female SLE subjects:
Exploratory Objective: Compare and characterize myeloid cell bioenergetic and immunometabolic profiles in healthy control and SLE female subjects
Endpoints:
Primary Endpoint:
The primary end point will be to assess the effect of NR on blunting type I IFN signaling by measuring monocytic secretion of IFN-beta secretion compared to baseline in response to placebo vs. NR supplemented in SLE study subjects.
Exploratory Endpoints:
Healthy control vs. SLE subjects:
* Compare type I IFN transcript profiles in monocytes and neutrophils at baseline and in response to activation.
* Assess cell bioenergetics including: 1) monocyte and neutrophil metabolic flux mass spectroscopy of 13C-glucose and 13Cglutamine analysis to investigate their metabolic fates; (iii) Mitochondrial oxygen consumption (using glucose, amino acid, and fatty acid substrates) and glycolysis rates.
SLE baseline vs. NR/placebo supplementation:
Baseline vs. 6 weeks of NR/placebo:
-Assess effect of NR on bioenergetics by measuring steady-state metabolite levels comparing changes in placebo vs. NR groups in monocytes and neutrophils.
Baseline vs. 12 weeks of NR/placebo:
* Whole blood NAD+ levels (batched and measured at the end of study enrollment period)
* Explore effects of NR on gene regulation using monocyte and neutrophils by RNA-seq and chromatin remodeling analysis.
* Determine the effect of NR vs placebo on endothelial dysfunction in SLE subjects