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Pharmacokinetic Analysis of Nicotinamide Riboside
Plain-language guide to NCT02300740: early phase 1 randomized trial of NAD+, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02300740
- Phase
- early phase 1
- Status
- completed
- Start
- 2014-12
- Completion (planned or actual)
- 2015-02
- Participants
- 12 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Participants
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (early phase 1) is built around NAD+.
Nicotinamide riboside is a newly discovered vitamin B3.
It had two arms (groups): one (experimental) and one (experimental).
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 12 actual participants took part.
It was open to men only aged from 18 years up to 30 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI 18-25, healthy, male,.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: liver or kidney diseases, other diseases.
How the Study Was Run
The set-up was randomized, crossover and open-label.
The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
In the crossover set-up each of the participants took both NAD+ and the comparison in turn, acting as their own control.
Everyone knew when NAD+ was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2014-12 with completion listed for 2015-02.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Serum nicotinamide riboside (time frame: 8 hours, blood samples every 15 min).
It also tracked 5 secondary outcomes, for example serum concentrations of metabolites of nicotinamide riboside, area under the curve for serum nicotinamide riboside, calculation of halftime of serum nicotinamide riboside, calculation of C-max of serum nicotinamide riboside and calculation of t-max of serum nicotinamide riboside.
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of NAD+ in 12 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.