Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-30 @ 1:37 AM
Study NCT ID:
NCT04271735
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 18-80 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.
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:
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:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 20-H-0044 | None | None | View |