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Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis
Plain-language guide to NCT04271735: not phased randomized trial of NAD+, atherosclerosis, cardiovascular disease & high blood pressure, 29 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04271735
- Phase
- not phased
- Status
- completed
- Start
- 2020-08-26
- Completion (planned or actual)
- 2022-12-19
- Participants
- 29 (actual)
- Design
- randomized, triple-blind, basic_science
- Conditions studied
- Psoriasis; Atherosclerotic Cardiovascular Disease; Obesity; Dyslipidemia; Cardiometabolic Diseases
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NAD+ for atherosclerosis, cardiovascular disease & high blood pressure and psoriasis and psoriatic arthritis.
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.
It had two arms (groups): Participants with mild to moderate Psoriasis receiving Placebo (placebo comparator) and Participants with mild to moderate Psoriasis receiving Nicotinamide Riboside (experimental).
The registry classes the interventions as dietary supplement and other.
More on the Plan
Study Description: Psoriasis is a Th17 linked inflammatory disease and the researchers 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 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.
Who Took Part
29 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
Groups ran in parallel: each of the atherosclerosis, cardiovascular disease & high blood pressure participants stayed in one arm throughout.
Blinding on both sides kept the atherosclerosis, cardiovascular disease & high blood pressure participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2020-08-26 with completion listed for 2022-12-19.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Mean Change in the TH17 Cell Cytokine IL-17 Secretion in Response to T-cell Differentiation (time frame: Baseline and Day 28).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 29 people with atherosclerosis, cardiovascular disease & high blood pressure.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the NAD+ compound page, Atherosclerosis, cardiovascular disease & high blood pressure research, Psoriasis and psoriatic arthritis research.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
- Atherosclerosis, cardiovascular disease & high blood pressure research
- Psoriasis and psoriatic arthritis research
- NAD+ in the library
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.