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

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ClinicalTrials.gov Identifier: NCT04271735
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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 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.


Condition or disease Intervention/treatment Phase
Psoriasis Atherosclerotic Cardiovascular Disease Obesity Dyslipidemia Cardiometabolic Diseases Dietary Supplement: Niagen Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Actual Study Start Date : August 26, 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Niacinamide

Arm Intervention/treatment
Experimental: NR arm
Subjects will take two capsules of nicotinamide riboside by mouth (250mg NR) twice daily for a total of 4 weeks.
Dietary Supplement: Niagen
Subjects will take two capsules of nicotinamide riboside by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.

Placebo Comparator: Placebo arm
Subjects will take two capsules of nicotinamide riboside by mouth (placebo) twice daily for a total of 4 weeks
Other: Placebo
placebo capsule to match the active supplement




Primary Outcome Measures :
  1. Evaluate the effect of NR on Th17 biology [ Time Frame: 28 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271735


Contacts
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Contact: Rebecca D Huffstutler, C.R.N.P. (301) 594-1281 rebecca.huffstutler@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Michael N Sack, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT04271735    
Other Study ID Numbers: 200044
20-H-0044
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 9, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Psoriasis
Dyslipidemias
Skin Diseases, Papulosquamous
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases