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Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis

Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis

Recruiting
18-70 years
All
Phase 2

Study Description:

Psoriasis is a Th17 linked inflammatory disease and we find that the vitamin B3 analogue nicotinamide riboside (NR) blunts Th1 and Th17 activation in ex-vivo na(SqrRoot) ve and differentiated T cells from control and psoriasis subjects. These findings supported the proposal of the following hypothesis. Supplementation with NR will blunt systemic immune activation in mild/moderate psoriasis.

Objectives
  1. Evaluate the effect of NR on Th17 biology
  2. Explore the effect of NR on neutrophils, specifically lowdensity granulocytes
  3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
  4. Evaluate the effect of NR on HDL regulated reverse cholesterol transport and lipid composition
Endpoints

The primary outcome will be the change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo. The comparisons will be performed using paired two-tailed Student t-tests. Significance will be tested at

the 0.05 alpha level in this pilot study.

Secondary outcomes are:

  1. Evaluate the effect of NR on the T cell transcriptome
  2. Explore the effect of NR on low-density granulocytes and neutrophils
  3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
  4. Evaluate the effect of NR on HDL regulated reverse cholesterol transport and lipid composition by NMR spectroscopy

Study Population:

Up to 40 male and female subjects of all races between the ages of 18-70 years with mild-moderate psoriasis who live locally will be screened.

Phase

N/A

Description of Sites/Facilities:

Enrollment and study visits will take place at the NIH Clinical Center.

Enrolling Participants:

Psoriatic Subjects

Description of Study Intervention:

Nicotinamide Riboside Chloride 500mg or placebo twice daily by mouth for 28 days.

Study Duration:

3 years

Participant Duration:

5-7 weeks

Study details
    Psoriasis
    Dyslipidemia
    Dyslipidemia
    Obesity
    Obesity
    Atherosclerotic Cardiovascular Disease
    Cardiometabolic Diseases

NCT04271735

National Heart, Lung, and Blood Institute (NHLBI)

19 February 2024

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