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Trial · Interventional

Not yet recruitingNot applicableRegistry data

Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.

NCTNCT07328100 (opens ClinicalTrials.gov in a new tab)Other idNAD-VA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Not applicable
Enrollment
60 participants (estimated)
Sponsor
Shanghai 10th People's Hospital · Other
Design
Randomized · Triple masking
Countries
1 country

China

Start
16 Jan 2026 (estimated)
Primary completion
30 Jun 2027 (estimated)
Completion
31 Dec 2027 (estimated)
First posted
8 Jan 2026
Last update posted
8 Jan 2026
Conditions
Vascular Aging · NAD

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. N/A

    Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.

    NCT07328100

    est. 16 Jan 2026 to est. 31 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Emerging evidence identifies vascular aging independently predicting cardiovascular events, yet effective clinical interventions remain lacking. Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor whose levels decline with age, and preclinical studies suggest that boosting NAD+ can improve vascular function and structure. Preliminary clinical studies in healthy older adults indicate that supplementation with NAD+ precursors, such as nicotinamide riboside(NR) or nicotinamide mononucleotide (NMN), can reduce arterial stiffness as measured by pulse wave velocity (PWV). However, whether NAD+ supplementation can improve vascular endothelial function and exert anti-stiffening effects in patients who have already developed measurable arterial stiffness remains unknown. Based on this evidence, the investigator hypothesize that the Coenzyme I for Injection will reverse vascular aging in older adults with established arterial stiffening.

Interventions

  • Coenzyme I for InjectionDrug
  • NaCl (placebo)Drug

Arms2

  • Experimental

    Intervention Group

  • Placebo comparator

    Control Group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The change in flow-mediated vasodilation(FMD)

    Time frame · Day 8/28

    Registry description

    Changes in FMD from baseline to day 8/28.

Secondary outcomes(6)

  1. Changes in cf-PWV.

    Time frame · day 8/28

    Registry description

    Changes in cf-PWV from baseline to day 8/28.

  2. Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)

    Time frame · day 8/28

    Registry description

    Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) from baseline to day 8/28.

  3. Changes in the level of NAD+

    Time frame · day 8/28

    Registry description

    Changes in the level of NAD+ from baseline to day 8/28.

  4. Changes in the metabolomics.

    Time frame · day 8/28

    Registry description

    Changes in the metabolomics from baseline to day 8/28.

  5. Changes in office blood pressure and 24-hour ambulatory blood pressure

    Time frame · day 8/28

    Registry description

    Changes in office blood pressure and 24-hour ambulatory blood pressure from baseline to day 8/28.

  6. The change in the urine albumin-to-creatinine ratio

    Time frame · day 8/28

    Registry description

    The change in the urine albumin-to-creatinine ratio from baseline to day 8/28.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Ages 40-70 years; 2. cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range; 3. Systolic Blood Pressure \< 160 mmHg and ≥ 140 mmHg or Diastolic BP \< 100 mmHg ≥ 90mmHg; 4. Signed informed consent. Exclusion Criteria: 1. Consumption of foods or medications containing high levels of NAD+, NR, NAM, NMN, or niacin-related components (including Vitamin B3 and natural health products) within 3 months prior to screening； 2. History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization； 3. Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg； 4. Diagnosis of malignant tumor； 5. Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components； 6. History of severe allergies or infusion reactions； 7. Women who are pregnant, breastfeeding, or planning pregnancy； 8. Severe hepatic or renal dysfunction: ALT or AST \> 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²； 9. Concurrent participation in another clinical trial without completion of the follow-up period； 10. Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.

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