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

December 4, 2023 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael N Sack, M.D.
  • Phone Number: (301) 402-9259
  • Email: ms761k@nih.gov

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Participants with mild to moderate Psoriasis receiving Placebo
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
Other: Placebo
Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
Experimental: Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
Dietary supplement: Niagen
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael N Sack, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

December 19, 2022

Study Completion (Actual)

December 19, 2022

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200044
  • 20-H-0044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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