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

Study Purpose

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 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

  • -

    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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04271735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael N Sack, M.D.
Principal Investigator Affiliation National Heart, Lung, and Blood Institute (NHLBI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis, Atherosclerotic Cardiovascular Disease, Obesity, Dyslipidemia, Cardiometabolic Diseases
Study Website: View Trial Website
Additional Details

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. 2. Explore the effect of NR on neutrophils, specifically lowdensity granulocytes. 3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects. 4. 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: 1. Evaluate the effect of NR on the T cell transcriptome. 2. Explore the effect of NR on low-density granulocytes and neutrophils. 3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects. 4. 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 18-80 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 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 Duration: 3 years. Participant Duration: 5-23 weeks

Arms & Interventions

Arms

Experimental: NR arm

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

Placebo Comparator: Placebo arm

Subjects will take two capsules of nicotinamide riboside by mouth (placebo) twice daily for a total of 4 weeks

Interventions

Dietary Supplement: - Niagen

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

Other: - Placebo

placebo capsule to match the active supplement

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

prpl@cc.nih.gov

800-411-1222 #TTY8664111010

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