Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis (NCT04271735) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
United States29 participantsStarted 2020-08-26
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation
Timeframe: Baseline and Day 28
Trial details
NCT IDNCT04271735
SponsorNational Heart, Lung, and Blood Institute (NHLBI)