Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
NCT ID: NCT04271735
Last Updated: 2023-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2020-08-26
2022-12-19
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
Placebo
Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
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.
Niagen
Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.
Interventions
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Niagen
Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.
Placebo
Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Michael N Sack, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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20-H-0044
Identifier Type: -
Identifier Source: secondary_id
200044
Identifier Type: -
Identifier Source: org_study_id