The NICE-PAD II Trial

What Was Tested

In this phase 3 trial, researchers set out to test NAD+.

The study will randomize 250 participants with PAD age 50 and older to one of two groups for six months: nicotinamide riboside vs placebo.

Their primary outcome is change in six-minute walk distance at six-month follow-up.

It had two arms (groups): Nicotinamide riboside (NR) (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 250 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

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

Examples of who could join: 1\. Age 50 and older.

The full record lists 2 inclusion and 18 exclusion criteria; among the exclusions: 1\. above- or below-knee amputation; 2\. critical limb ischemia defined as an abi \<0.40 with symptoms of rest pain; 3\. wheelchair confinement or requiring a walker to ambulate.

How the Study Was Run

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

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

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

It started in 2026-12 with completion listed for 2030-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Six-minute walk distance (time frame: Baseline to 6-months).

It also tracked 6 secondary outcomes, for example Walking Impairment Questionnaire (WIQ) distance score, PROMIS Mobility score, Calf muscle perfusion, Oxidative stress, NAD+ and 6-minute walk.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of NAD+ in 250 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.