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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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 133 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 13 versions Re-verified since Sep 7, 2024, no change to tracked fieldsv121-v133
  2. Minor Eligibility criteria shortened, about 10 wordsv120
  3. Minor Eligibility criteria expanded, about 33 wordsv119
  4. Minor 6 versions Re-verified since Mar 30, 2024, no change to tracked fieldsv113-v118
  5. Minor Eligibility criteria expanded, about 6 wordsv112
Show 28 earlier versionsHide 28 earlier versions
  1. Minor Start date changed from estimate of Mar 20, 2024 to Mar 13, 2024v111
  2. Minor Start date: Mar 18, 2024 to Mar 20, 2024v110
  3. Minor Start date: Mar 17, 2024 to Mar 18, 2024v109
  4. Minor Start date: Mar 14, 2024 to Mar 17, 2024v108
  5. Minor Start date: Mar 13, 2024 to Mar 14, 2024v107
  6. Minor Start date: Mar 12, 2024 to Mar 13, 2024v106
  7. Minor Start date: Mar 11, 2024 to Mar 12, 2024v105
  8. Minor Start date: Mar 10, 2024 to Mar 11, 2024v104
  9. Minor Start date: Mar 7, 2024 to Mar 10, 2024v103
  10. Minor Start date: Mar 6, 2024 to Mar 7, 2024v102
  11. Minor Start date: Mar 5, 2024 to Mar 6, 2024v101
  12. Minor Start date: Mar 4, 2024 to Mar 5, 2024v100
  13. Minor Start date: Feb 29, 2024 to Mar 4, 2024v99
  14. Minor Start date: Feb 28, 2024 to Feb 29, 2024v98
  15. Minor Start date: Feb 27, 2024 to Feb 28, 2024v97
  16. Minor Start date: Feb 26, 2024 to Feb 27, 2024v96
  17. Minor Start date: Feb 25, 2024 to Feb 26, 2024v95
  18. Minor Start date: Feb 22, 2024 to Feb 25, 2024v94
  19. Minor Start date: Feb 20, 2024 to Feb 22, 2024v93
  20. Minor Start date: Feb 19, 2024 to Feb 20, 2024v92
  21. Minor Start date: Feb 18, 2024 to Feb 19, 2024v91
  22. Minor Start date: Feb 15, 2024 to Feb 18, 2024v90
  23. Minor Start date: Feb 14, 2024 to Feb 15, 2024v89
  24. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 12, 2024 to Feb 14, 2024
    • Site details revised
    v88
  25. Minor Start date: Feb 11, 2024 to Feb 12, 2024v87
  26. Minor Start date: Feb 7, 2024 to Feb 11, 2024v86
  27. Minor Start date: Feb 6, 2024 to Feb 7, 2024v85
  28. Minor Start 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
Trial Details
NCT Number NCT06032923
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Systemic Lupus Erythematosus (Sle)
Related terms Lupus Erythematosus, Systemic
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov