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Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD
Plain-language guide to NCT04040959: phase 2 randomized trial of NAD+, low blood pressure and orthostatic hypotension, 118 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04040959
- Phase
- phase 2
- Status
- active, not recruiting
- Start
- 2019-11-19
- Completion (planned or actual)
- 2026-07-20
- Participants
- 118 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Vascular Diseases; Kidney Disease; Blood Pressure; Oxidative Stress
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test NAD+ for low blood pressure and orthostatic hypotension.
It had two arms (groups): Nicotinamide Riboside (experimental) and Placebo (placebo comparator).
Matched placebo capsules.
The registry classes the interventions as drug.
More on the Plan
While many changes likely contribute to the development of arterial dysfunction in patients with CKD, among those of greatest concern is the development of stiffening of the large elastic arteries.
Primary Outcome Measure (Aim 1): Aortic stiffness will be evaluated as CFPWV, the gold-standard measurement technique and clinically relevant marker of vascular function.
CFPWV will be measured before and after 3 months of treatment with nicotinamide riboside or placebo.
Secondary Outcome Measures (Aim 2): Casual and ambulatory SBP will be the main secondary outcomes measures: (a) Casual (resting) SBP will be measured according to American Heart Association/American College of Cardiology guidelines, with an automated oscillometric sphygmomanometer.
Who Took Part
The registry lists 118 planned participants were the target.
It was open to people of any sex aged from 35 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 35-80 years;. Ability to provide informed consent;. Willing to accept random assignment to condition;. Blood pressure controlled to \<140/90 mmHg for the past 3 months;. Body mass index \<40 kg/m2;.
The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: patients with advanced ckd requiring chronic dialysis;; hospitalization in the past month;; immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, etanercept, infliximab, adalimumab, anakinra or long-term oral glucocorticoids taken in past 12 months;.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
The low blood pressure and orthostatic hypotension participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
Groups ran in parallel: each of the low blood pressure and orthostatic hypotension participants stayed in one arm throughout.
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 2019-11-19 with completion listed for 2026-07-20.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: carotid-femoral pulse wave velocity (time frame: Baseline and 3 months).
It also tracked 2 secondary outcomes, for example Systolic blood pressure and Systolic blood pressure.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of NAD+ in 118 people with low blood pressure and orthostatic hypotension.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, Low blood pressure and orthostatic hypotension research.
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.