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

Not Applicable

Completed

• Conditions: Obesity; Cardiometabolic Diseases; Atherosclerotic Cardiovascular Disease; Dyslipidemia; Psoriasis
• Interventions: Dietary Supplement: Niagen; Other: Placebo

• Registration Number: NCT04271735
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-17
• Study Start: 2020-08-26
• Primary Completion: 2022-12-19
• Study Completion: 2022-12-19
• Status Verified: 2023-03
• Results First Submitted: 2023-12-04
• Results First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Results First Posted: 2023-12-27
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside	Niagen	Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
Participants with mild to moderate Psoriasis receiving Placebo	Placebo	Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.

Primary Outcome Measures

Name	Time	Method
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation	Baseline and Day 28	Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States