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

A Randomized, Double-blind, Parallel Controlled Clinical Trial to Evaluate the Efficacy of Coenzyme I for Injection in the Treatment of Vascular Aging（Pilot Stydy）

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NAD; Vascular Aging
• Intervention / Treatment: Drug: Coenzyme I for Injection; Drug: NaCl (placebo)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang; Phone Number: 18917686332; Email: yizshcn@gmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Drug: Coenzyme I for Injection; Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.
Placebo Comparator: Control Group	Drug: NaCl (placebo); Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in flow-mediated vasodilation(FMD)	Changes in FMD from baseline to day 8/28.	Day 8/28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cf-PWV.	Changes in cf-PWV from baseline to day 8/28.	day 8/28
Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)	Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR) from baseline to day 8/28.	day 8/28
Changes in the level of NAD+	Changes in the level of NAD+ from baseline to day 8/28.	day 8/28
Changes in the metabolomics.	Changes in the metabolomics from baseline to day 8/28.	day 8/28
Changes in office blood pressure and 24-hour ambulatory blood pressure	Changes in office blood pressure and 24-hour ambulatory blood pressure from baseline to day 8/28.	day 8/28
The change in the urine albumin-to-creatinine ratio	The change in the urine albumin-to-creatinine ratio from baseline to day 8/28.	day 8/28

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 28, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Nucleic Acids, Nucleotides, and Nucleosides; Enzymes and Coenzymes; Purines; Coenzymes; Ribonucleotides; Nucleotides; Adenine Nucleotides; Purine Nucleotides; Injections; NAD
• Other Study ID Numbers: NAD-VA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No