Protocol Details
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
This study is NOT currently recruiting participants.
Summary
Number |
20-H-0044 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Chronic Inflammatory Skin Disease;
Systemic Inflammation-Induced Atherosclerosis;
TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation;
Effect of NR on Neutrophils;
Effect of NR on HDL |
Recruitment Keyword(s) |
None |
Condition(s) |
Psoriasis;
Atherosclerotic Cardiovascular Disease;
Obesity;
Dyslipidemia;
Cardiometabolic Diseases |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Dietary Supplement: Niagen
Other: Placebo
|
Supporting Site |
National Heart, Lung, and Blood Institute |
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.
Eligibility
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT04271735