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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.