PsoriasisNCT04271735
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
A study testing Niagen in people with Psoriasis and Atherosclerotic Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis, Atherosclerotic Cardiovascular Disease, Obesity
- What is being tested?
- Niagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 19 Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Psoriasis, Atherosclerotic Cardiovascular Disease, Obesity, Dyslipidemia, Cardiometabolic Diseases
- Being tested
- Niagen, Placebo
- Keywords
- Chronic Inflammatory Skin Disease, Systemic Inflammation-Induced Atherosclerosis, TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation, Effect of NR on Neutrophils, Effect of NR on HDL
- Medical subject headings
- Psoriasis, Atherosclerosis, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiagenDietary supplement
Also called Nicotinamide Riboside Chloride, Nicotinamide Riboside
Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.
PlaceboOther
Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Participants with mild to moderate Psoriasis receiving Placebo | Placebo comparator | Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days. Receives: Other: Placebo |
| Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside | Experimental | Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days. Receives: Dietary Supplement: Niagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start26 Aug 2020
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rachael J Klein, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271735
- Sponsor's protocol ID
- 200044
- Other IDs
- 20-H-0044
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2020
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han K, Klein RJ, Recupero TC, Russo AC, Sharma R, Gupta AK, Hassanzadeh S, Huffstutler RD, Dagur PK, Fisk B, Redekar NR, Sack MN. NAD+ augmentation by nicotinamide riboside engages SLIT2/ROBO1 signaling to attenuate Th17 inflammation in psoriasis. JCI Insight. 2026 Apr 28;11(12):e203826. doi: 10.1172/jci.insight.203826. eCollection 2026 Jun 22.
PubMed 42048163