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Nicotinamide Riboside in Hospitalized Patients

Plain-language guide to NCT04110028: phase 1, phase 2 randomized trial of NAD+, 57 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04110028
Phase
phase 1, phase 2
Status
completed
Start
2019-10-01
Completion (planned or actual)
2022-12-01
Participants
57 (actual)
Design
randomized, quadruple-blind, supportive_care
Conditions studied
Inflammation; Acute Illness
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1, phase 2 trial tested NAD+.

Patients will receive oral nicotinamide riboside or placebo and clinical and paraclinical outcome will be determined.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Patients experiencing acute illness will often have a prolonged recovery time.

Who Took Part

Enrollment: 57 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Preferably: Previously included in the Janus Cohort or any other cohort or study with stored biological samples.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: allergy to nr or ingredients in capsules or placebo; patients expected to pass away within 90 days; patients unable to give their consent.

How the Study Was Run

It was run as a randomized, sequential and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

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 2019-10-01 with completion listed for 2022-12-01.

It ran at 1 site in Norway.

Its stated primary purpose is supportive care.

What Was Measured

It also tracked 37 secondary outcomes, for example Time to normalization of urine production, Mortality, Time to normalization of blood pressure, Change in blood pressure during the study period, Days on respiratory support and Number of days with temperature above 38 at any point from inclusion to discharge.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 57 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.