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"Pharmacokinetic Study of Nicotinamide Riboside"

Plain-language guide to NCT02689882: phase 1 interventional trial of NAD+, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02689882
Phase
phase 1
Status
completed
Start
2015-11
Completion (planned or actual)
2015-12
Participants
8 (actual)
Design
na, open label (everyone knows who gets what), other
Conditions studied
Metabolic Disturbance
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 1 trial tested NAD+.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

If the potassium is greater than 5.5, a repeat value and an ECG will be performed and the Study Investigator.

If it is greater than 6.0, the Study Investigator will evaluate the subject for admission. 4.

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 21 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy, adult (age 21-50 years), male or female. Willing and able to provide informed consent.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: current smoking; receiving concurrent medications or supplements; history of liver, renal, cardiovascular, endocrine, or neurological disease.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label NAD+ study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-11 with completion listed for 2015-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

It also tracked 5 secondary outcomes, for example Effect of nicotinamide riboside on serum potassium levels, Effect of nicotinamide riboside on serum creatine kinase levels, Effect of nicotinamide riboside on serum glucose levels, Effect of nicotinamide riboside on serum uric acid levels and Effect of nicotinamide riboside on serum alanine aminotransferase levels.

What This Means in Plain Language

Put simply, this is a phase 1 trial of NAD+ in 8 people.

Its size is small, so on its own it can only give an early look.

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.