Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
-
- STATUS
- Recruiting
-
- participants needed
- 40
-
- sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
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.
- 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 18-70 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.
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
- Explore the effect of NR on neutrophils, specifically lowdensity granulocytes
- Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
- 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:
- Evaluate the effect of NR on the T cell transcriptome
- Explore the effect of NR on low-density granulocytes and neutrophils
- Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
- 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 18-70 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.
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:
5-7 weeks
Details
| Condition | Psoriasis, Dyslipidemia, Dyslipidemia, Obesity, Obesity, Atherosclerotic Cardiovascular Disease, Cardiometabolic Diseases |
|---|---|
| Age | 18-70 years |
| Treatment | Placebo, Niagen |
| Clinical Study Identifier | NCT04271735 |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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