Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atherosclerotic Cardiovascular Disease
- Cardiometabolic Diseases
- Dyslipidemia
- Obesity
- Psoriasis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
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...
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: Evaluate the effect of NR on Th17 biology Explore the effect of NR on neutrophils, specifically lowdensity granulocytes Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects 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: Evaluate the effect of NR on the T cell transcriptome Explore the effect of NR on low-density granulocytes and neutrophils Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects 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 or via telehealth visits. 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: 5-23 weeks
Tracking Information
- NCT #
- NCT04271735
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michael N Sack, M.D. National Heart, Lung, and Blood Institute (NHLBI)
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