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Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease

Plain-language guide to NCT03579693: phase 2 randomized trial of NAD+, 26 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03579693
Phase
phase 2
Status
completed
Start
2018-11-14
Completion (planned or actual)
2021-04-26
Participants
26 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Chronic Kidney Disease; Sarcopenia; Frailty
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested NAD+.

This process detrimentally impacts mobility, functional independence, and quality of life.

It had three arms (groups): CoQ10 (active comparator), Nicotinamide riboside (active comparator) and Placebo (placebo comparator).

Placebo, inactive sugar pill for 6 weeks.

The registry classes the interventions as dietary supplement.

More on the Plan

However, the ability of treatments to modify mitochondrial functioning in CKD patients is unknown.

This is a randomized, placebo-controlled, double-blind crossover trial of coQ10 and NR treatments.

The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry.

Who Took Part

Enrollment: 26 actual participants took part.

It was open to people of any sex aged from 30 years up to 79 years.

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

The full record lists 1 inclusion and 22 exclusion criteria; among the exclusions: 6-minute walking distance \>500meters; expectation to start dialysis within 6 months; hyperkalemia: k \>5.7 meq/l.

How the Study Was Run

It was run as a randomized, crossover and triple-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.

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

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

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

It started in 2018-11-14 with completion listed for 2021-04-26.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximal Aerobic Capacity- CoQ10 (time frame: 6 weeks). Work Efficiency (time frame: 6 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 26 people.

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

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.