Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Condition: Psoriasis; Atherosclerotic Cardiovascular Disease; Obesity; Dyslipidemia; Cardiometabolic Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Psoriasis; Dyslipidemias
Study type: Interventional

Summary: 
      Background:

      Psoriasis causes chronic inflammation in the body. Researchers want to see if a kind of
      vitamin B3 dietary supplement can help. This might lead to more treatment options.

      Objective:

      To test if the dietary supplement nicotinamide riboside can improve immune system function in
      the blood and skin of people with mild to moderate psoriasis.

      Eligibility:

      People ages 18-80 with mild to moderate active psoriasis not currently treated with
      biological therapy

      Design:

      Participations will be screened with:

        -  Medical and medication history

        -  Physical exam

        -  Measure of body mass index

        -  Skin exam

        -  Blood and urine tests

      Participants will have visit 1. They will have repeats of the screening tests. They may also
      have 2 skin biopsies, which are optional. These will be from both lesions and unaffected
      areas. The areas will be injected with a numbing medicine. A round cutting device will remove
      small pieces of skin from each area.

      Participants will take the study supplement or a placebo starting at the first visit. Neither
      participants nor the study team will know which they receive. Participants will take capsules
      twice daily for a total of 4 weeks.

      Participants will then have visit 2. This will include the tests performed at visit 1.

      Participants may by contacted by phone or email between visits to see how they are doing.

      If participants develop any side effects in the 7 days after they stop taking the capsules,
      they may have another visit.
    

Detailed 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 following hypothesis. Supplementation with NR will blunt systemic immune
      activation in mild/moderate psoriasis.

      Objectives:

      1) Evaluate the effect of NR on Th17 biology

      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.

      Exploratory 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

      Study Population:

      Up to 40 male and female subjects of all races between the ages of 18-80 years with
      mild-moderate psoriasis who live locally will be screened.

      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.
    

Intervention name(s): Niagen; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.; Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
Other intervention name(s): Nicotinamide Riboside Chloride; Nicotinamide Riboside
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Chronic Inflammatory Skin Disease; Systemic Inflammation-Induced Atherosclerosis; TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation; Effect of NR on Neutrophils; Effect of NR on HDL