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

STATUS

Recruiting
participants needed

40
sponsor

National Heart, Lung, and Blood Institute (NHLBI)

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Updated on 19 February 2024

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body mass index

vitamins

niacin

urine test

psoriasis

chronic inflammation

nicotinamide

nicotinamide riboside

Summary

Show definitions

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 18-70 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 will also have 2 skin biopsies. 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.

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

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.

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

Details

Condition	Psoriasis, Dyslipidemia, Dyslipidemia, Obesity, Obesity, Atherosclerotic Cardiovascular Disease, Cardiometabolic Diseases
Age	18years - 70years
Treatment	Placebo, Niagen
Clinical Study Identifier	NCT04271735
Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Individuals must meet all inclusion criteria listed below in order to be
	eligible to participate in the study
	Males and females between the ages of 18 and 70 with mild to moderate active psoriasis
	Female subjects of child-bearing ability willing to commit to reliable contraception while participating in the study
	Ability to provide informed consent
	Willingness and ability to participate in required study procedures
Exclusion Criteria
	Severe psoriasis by PASI (Psoriasis Area and Severity Index) score > 12
	Currently being treated with biologic immune modifying agents
	Currently on treatment for allergies or other inflammatory diseases
	Has taken Vitamin B or tryptophan supplementation within 2 weeks of participation
	Unwillingness/inability to provide informed consent
	ALT > x3 upper limit of normal, hepatic insufficiency or active liver disease
	Recent history of acute gout
	Chronic renal insufficiency with creatinine > 2.5mg/dl
	Pregnant (or attempting to become pregnant) women
	Current participation in another drug study
	History of intolerance to NR precursor compounds, including niacin or nicotinamide
	Study adherence concerns
	Individuals with diabetes type 1 and 2 who use insulin
	Women of child-bearing potential unwilling to use contraception or unwilling to practice abstinence
	Breastfeeding women unwilling to stop breastfeeding

How to participate?

Step 1 Connect with a study center

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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