Status:
COMPLETED
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Psoriasis
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 dif...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Individuals must meet all inclusion criteria listed below in order to be eligible to participate in the study.
- Males and females between the ages of 18 and 80 with mild to moderate active psoriasis.
- 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:
- Severe psoriasis by PASI (Psoriasis Area and Severity Index) score \> 12
- 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
Exclusion
Key Trial Info
Start Date :
August 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04271735
Start Date
August 26 2020
End Date
December 19 2022
Last Update
December 27 2023
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892