Trial Outcomes & Findings for Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis (NCT NCT04271735)
NCT ID: NCT04271735
Last Updated: 2023-12-27
Results Overview
Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Baseline and Day 28
Results posted on
2023-12-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
12
|
|
Overall Study
COMPLETED
|
15
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Baseline characteristics by cohort
| Measure |
Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside
n=17 Participants
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
|
Participants With Mild to Moderate Psoriasis Receiving Placebo
n=12 Participants
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28Population: One participant from placebo group not included in analysis due to insufficient T-cells. One participant from Nicotinamide Riboside group not included in analysis due to abnormal lipids.
Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo.
Outcome measures
| Measure |
Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside
n=14 Participants
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
|
Participants With Mild to Moderate Psoriasis Receiving Placebo
n=11 Participants
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
|
|---|---|---|
|
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
|
-176.9 pg/mL
Standard Deviation 174.7
|
-7.2 pg/mL
Standard Deviation 120.9
|
Adverse Events
Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants With Mild to Moderate Psoriasis Receiving Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants With Mild to Moderate Psoriasis Receiving Nicotinamide Riboside
n=17 participants at risk
Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.
|
Participants With Mild to Moderate Psoriasis Receiving Placebo
n=12 participants at risk
Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.
|
|---|---|---|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/12 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
0.00%
0/12 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/17 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
8.3%
1/12 • Number of events 1 • Up to day 35
Grade 2 - 5 adverse events and serious adverse events whether volunteered by the patient, discovered by study personnel during questioning, or detected through physical examination, clinically significant laboratory test, or other means will be recorded.
|
Additional Information
Michael Sack, M.D. Principal Investigator, NIH, NHLBI
National Heart Lung and Blood Institute (NHLBI)
Phone: 301.402.9259
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place