An interventional study of Niagen and Placebo in Psoriasis, Atherosclerotic Cardiovascular Disease and Obesity, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Not applicable, Interventional, and Basic science
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:
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 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:
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 29 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals must meet all inclusion criteria listed below in order to be eligible to participate in the study.
EXCLUSION CRITERIA:
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
Other: Placebo
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.
Also known as: Nicotinamide Riboside Chloride, Nicotinamide Riboside
Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
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.
Time frame: Baseline and Day 28
| Milestone | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo |
|---|---|---|
| Started | 17 | 12 |
| Completed | 15 | 12 |
| Not completed | 2 | 0 |
| Withdrew: Physician decision | 2 | 0 |
Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.
| pg/mL | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo |
|---|---|---|
| Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation | -176.9 ± 174.7 | -7.2 ± 120.9 |
Collected over Up to day 35. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | 0/17 (0%) | 0/17 (0%) | 1/17 (5.9%) |
| Participants With Mild to Moderate Psoriasis Receiving Placebo | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo |
|---|---|---|
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 0/17 | 1/12 |
| FatigueGeneral disorders | 1/17 | 0/12 |
| NauseaGastrointestinal disorders | 1/17 | 0/12 |
| Age, Categorical(Participants) | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 10 | 24 |
| >=65 years | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 12 | 6 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 15 | 8 | 23 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 13 | 9 | 22 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside | Participants With Mild to Moderate Psoriasis Receiving Placebo | Total |
|---|---|---|---|
| United States | 17 | 12 | 29 |
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National Heart, Lung, and Blood Institute (NHLBI)