Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    40
  • sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
Updated on 7 October 2022
body mass index
vitamins
niacin
Accepts healthy volunteers

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 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.

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 differentiated T cells from control and psoriasis subjects. These findings supported the proposal of the following hypothesis. Supplementation with NR will blunt systemic immune activation in mild/moderate psoriasis.

Objectives
  1. Evaluate the effect of NR on Th17 biology
  2. Explore the effect of NR on neutrophils, specifically lowdensity granulocytes
  3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
  4. Evaluate the effect of NR on HDL regulated reverse cholesterol transport and lipid composition
Endpoints

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. The comparisons will be performed using paired two-tailed Student t-tests. Significance will be tested at

the 0.05 alpha level in this pilot study.

Secondary outcomes are:

  1. Evaluate the effect of NR on the T cell transcriptome
  2. Explore the effect of NR on low-density granulocytes and neutrophils
  3. Evaluate whether NR modulates keratinocyte activation in skin lesions in psoriatic subjects
  4. Evaluate the effect of NR on HDL regulated reverse cholesterol transport and lipid composition by NMR spectroscopy

Study Population:

Up to 40 male and female subjects of all races between the ages of 18-80 years with mild-moderate psoriasis who live locally will be screened.

Phase

N/A

Description of Sites/Facilities:

Enrollment and study visits will take place at the NIH Clinical Center or via telehealth visits.

Enrolling Participants:

Psoriatic Subjects

Description of Study Intervention:

Nicotinamide Riboside Chloride 500mg or placebo twice daily by mouth for 28 days.

Study Duration:

3 years

Participant Duration:

5-23 weeks

Details
Condition Psoriasis, Atherosclerotic Cardiovascular Disease, Obesity, Dyslipidemia, Cardiometabolic Diseases
Treatment Placebo, Niagen
Clinical Study IdentifierNCT04271735
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Ability to provide informed consent
Female subjects of child-bearing ability willing to commit to reliable contraception
Willingness and ability to participate in required study procedures
while participating in the study

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
Unwillingness/inability to provide informed consent
ALT > x3 upper limit of normal, hepatic insufficiency or active liver disease
Currently taking a multivitamin, Vitamin B or tryptophan supplementation and unwilling
to stop within 2 weeks of baseline visit
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
Breastfeeding women unwilling to stop breastfeeding
Women of child-bearing potential unwilling to use contraception or unwilling to
practice abstinence
Immunization administered within 30 days of participation and no plans for
immunization while participating in the study
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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