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

NCT04271735 | Completed Results

• 2 other identifiers: 20004420-H-0044
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Psoriasis; Atherosclerotic Cardiovascular Disease; Obesity; Dyslipidemia; Cardiometabolic Diseases

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Participants with mild to moderate Psoriasis receiving Placebo

PLACEBO COMPARATOR

Participants with mild to moderate Psoriasis receiving placebo (2 capsules) twice daily by mouth for 28 days.

Other: Placebo

Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside

EXPERIMENTAL

Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside Chloride 500mg (2 capsules) twice daily by mouth for 28 days.

Dietary Supplement: Niagen

Interventions

Niagen DIETARY_SUPPLEMENT

Participants will take two capsules of nicotinamide riboside (NR) by mouth (250mg NR or placebo) twice daily for a total of 4 weeks.

Also known as: Nicotinamide Riboside Chloride, Nicotinamide Riboside

Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside

Placebo OTHER

Placebo capsule to match the active supplement. Participants will take two capsules, twice daily for a total of 4 weeks.

Participants with mild to moderate Psoriasis receiving Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Psoriasis; Atherosclerosis; Obesity; Dyslipidemias

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases

Results Point of Contact

• Title: Michael Sack, M.D. Principal Investigator, NIH, NHLBI
• Organization: National Heart Lung and Blood Institute (NHLBI)

sackm@nhlbi.nih.gov

301.402.9259

Study Officials

• Michael N Sack, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 17, 2020
• Study Start: August 26, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: December 27, 2023
• Results First Posted: December 27, 2023

Record last verified: 2023-03

Locations

US (1)