Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04271735
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-02-14
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:
National Institutes of Health Clinical Center CC
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 naSqrRoot 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 mildmoderate 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 005 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 naSqrRoot 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 mildmoderate 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 005 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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-H-0044 | None | None | None |