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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-H-0044

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Children

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

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: Niagen
Other: Placebo

Supporting Site

National Heart, Lung, and Blood Institute

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.

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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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Michael N. Sack, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 5-3342
10 CENTER DR
BETHESDA MD 20892
(301) 402-9259
ms761k@nih.gov

Rebecca D. Huffstutler, C.R.N.P.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CRC BG RM 5-1462
10 CENTER DR
BETHESDA MD 20892
(301) 594-1281
rebecca.huffstutler@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04271735

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