← Human Trials & Peer-Reviewed Studies
Inflammation in COPD and the Effect of Nicotinamide Riboside
Plain-language guide to NCT04990869: not phased randomized trial of NAD+, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04990869
- Phase
- not phased
- Status
- completed
- Start
- 2021-08-05
- Completion (planned or actual)
- 2022-08-18
- Participants
- 60 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- COPD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test NAD+.
A major event in aging is the loss of the central metabolite nicotinamide adenine dinucleotide (NAD+) that appear to be important in the proinflammatory environment that occur during aging.
It had four arms (groups): COPD-NR (experimental), COPD-placebo (placebo comparator), Control-NR (experimental) and Control-placebo (placebo comparator).
COPD patients receiving Nicotinamide Riboside.
COPD patients receiving placebo.
The registry classes the interventions as dietary supplement.
More on the Plan
A major event in aging is the loss of nicotinamide adenine dinucleotide (NAD+)-a loss which may be important in promoting the pro-inflammatory environment that occur with aging and therefore possibly COPD.
Indeed, NAD+ is emerging as a central metabolic molecule involved in multiple age-related pathways including inflammation and metabolic control.
In humans, the therapeutic potential of boosting NAD+ levels through supplementation with one of its more bioavailable precursors has therefore gained attention.
This vitamin B3-analog is naturally occurring, is readily taken up through oral administration and has been tested in human trials with few side effects.
Who Took Part
The registry lists 60 actual participants took part.
It was open to people of any sex aged from 60 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Written informed consent. Age 60 or older. A body mass index (BMI) between 18.5-40.0 kg·m-2 and a weight ≥ 40 kg at enrolment. A diagnosis of chronic obstructive pulmonary disease (FEV1/FVC \< 0.7). Smoking history of at least 10 pack years, but currently ex-smoker.
The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: exacerbation of copd or severe airway infection within the last two months; chronic use of supplements containing vitamin b or nr; planned surgery during the course of the trial.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.
The NAD+ group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2021-08-05 with completion listed for 2022-08-18.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Interleukin-8 (time frame: 6 weeks).
It also tracked 6 secondary outcomes, for example NAD+ levels, Interleukin-6, Interleukin-10, Tumor necrosis factor alpha, C-reactive protein and Matrix metalloproteinase-9.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of NAD+ in 60 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
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.