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NOT YET RECRUITING
NCT07782671
PHASE3

The NICE-PAD II Trial

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

Among people with peripheral artery disease (PAD) age 50 and older, the investigators will test the hypothesis that PAD participants randomized to nicotinamide riboside (NR) will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 250 participants with PAD age 50 and older to one of two groups for six months: nicotinamide riboside vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Walking Impairment Questionnaire (WIQ) distance score, PROMIS Mobility score, calf muscle perfusion (measured by magnetic resonance arterial spin labeling (MRI ASL)), oxidative stress (measured by plasma oxidized LDL), NAD+ abundance in whole blood, 6-minute walk improvement by baseline whole blood NAD+ levels, and 6-minute walk distance at 4 weeks after intervention completion. To achieve the specific aims, the study will randomize 250 participants age 50 and older with PAD to one of two groups: nicotinamide riboside vs placebo. Participants will be followed for six months, with an additional four-week follow-up period after completion of the study intervention.

Official title: Nicotinamide Riboside to Improve Functioning in PAD

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-12

Completion Date

2031-07

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

DRUG

Nicotinamide Riboside (NR)

The nicotinamide riboside intervention is manufactured by ChromaDex. Participants randomized to nicotinamide riboside will take two capsules twice daily. Each capsule contains 250 mg of nicotinamide riboside, for a total of 1000 mg of nicotinamide riboside per day.

DRUG

Placebo

The placebo is manufactured by ChromaDex and is visually identical to the nicotinamide riboside capsules. Participants randomized to placebo will take two capsules twice daily. The placebo will not contain any nicotinamide riboside.