Obesity Clinical Trial
Official title:
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Verified date | March 2023 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | December 19, 2022 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation | Mean change in the TH17 cell cytokine IL-17 secretion in response to T-cell differentiation comparing the baseline versus NR or placebo. | Baseline and Day 28 |
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