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Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease

Plain-language guide to NCT03743636: phase 3 randomized trial of NAD+, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03743636
Phase
phase 3
Status
completed
Start
2018-10-01
Completion (planned or actual)
2023-05-23
Participants
90 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Peripheral Artery Disease
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around NAD+.

If findings support the hypotheses, results will be used to design a large, definitive randomized clinical.

The study will randomize 90 participants with PAD to one of the following three groups: NR + resveratrol, NR + placebo, or placebo + placebo.

It had three arms (groups): Nicotinamide riboside + resveratrol (active comparator), Nicotinamide riboside + placebo (active comparator) and Placebo + placebo (placebo comparator).

Participants randomized to the placebo + placebo arm of study will receive placebo pills.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 90 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.

The full record lists 0 inclusion and 20 exclusion criteria; among the exclusions: above- or below-knee amputation; critical limb ischemia; wheelchair-bound or requiring a walker to ambulate.

How the Study Was Run

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

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The NAD+ group and the comparison group ran side by side rather than switching.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-10-01 with completion listed for 2023-05-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Six-minute Walk Distance (NR Alone vs. Placebo) (time frame: Baseline to 6-month follow-up). Six-minute Walk Distance (NR/Resveratrol vs. Placebo) (time frame: Baseline to 6-month follow-up).

It also tracked 21 secondary outcomes, for example Six-minute Walk Distance (NR Alone vs. Placebo), Six-minute Walk Distance (NR/Resveratrol vs. Placebo), Six-minute Walk Distance (NR/Resveratrol vs. NR Alone), Six-minute Walk Distance (NR/Resveratrol vs. NR Alone), Maximal Treadmill Walking Time (NR Alone vs. Placebo) and Walking Impairment Questionnaire (WIQ) Distance Score (NR Alone vs. Placebo).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of NAD+ in 90 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.