Completed

NCT Number: NCT04271735

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

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.

Completed

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Key information

Conditions

Psoriasis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Body Weight Cardiometabolic Diseases Cardiovascular Diseases Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

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

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:

Evaluate the effect of NR on the T cell transcriptome
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 80 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.
Currently taking a multivitamin, Vitamin B or tryptophan supplementation and unwilling to stop within 2 weeks of baseline visit.
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
Immunization administered within 30 days of participation and no plans for immunization while participating in the study

Treatment and study plan

Niagen

Dietary Supplement

Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.

Other names: Nicotinamide Riboside Chloride, Nicotinamide Riboside

Placebo

Other

Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.

Primary outcomes

Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Feb 17, 2020
Registry last updated: Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed