Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
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|ClinicalTrials.gov Identifier: NCT04271735|
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : November 17, 2021
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.
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.
People ages 18-80 with mild to moderate active psoriasis not currently treated with biological therapy
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Atherosclerotic Cardiovascular Disease Obesity Dyslipidemia Cardiometabolic Diseases||Dietary Supplement: Niagen Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis|
|Actual Study Start Date :||August 26, 2020|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: NR arm
Subjects will take two capsules of nicotinamide riboside by mouth (250mg NR) twice daily for a total of 4 weeks.
Dietary Supplement: Niagen
Subjects will take two capsules of nicotinamide riboside by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.
Placebo Comparator: Placebo arm
Subjects will take two capsules of nicotinamide riboside by mouth (placebo) twice daily for a total of 4 weeks
placebo capsule to match the active supplement
- Evaluate the effect of NR on Th17 biology [ Time Frame: 28 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271735
|Contact: Rebecca D Huffstutler, C.R.N.P.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Michael N Sack, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|