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

NCT07328100 | Not Yet Recruiting

• 1 other identifier: NAD-VA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NAD; Vascular Aging

Outcome Measures

Primary Outcomes (1)

• The change in flow-mediated vasodilation(FMD)

  Changes in FMD from baseline to day 8/28.

  Day 8/28

Secondary Outcomes (6)

• Changes in cf-PWV.

  day 8/28

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

  day 8/28

• Changes in the level of NAD+

  day 8/28

• Changes in the metabolomics.

  day 8/28

• Changes in office blood pressure and 24-hour ambulatory blood pressure

  day 8/28

Study Arms (2)

Intervention Group

EXPERIMENTAL

Drug: Coenzyme I for Injection

Control Group

PLACEBO COMPARATOR

Drug: NaCl (placebo)

Interventions

Coenzyme I for Injection DRUG

Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.

Intervention Group

NaCl (placebo) DRUG

Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).

Control Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 40-70 years;
• cf-PWV was abnormally elevated and above the upper limit of its age-and blood-pressure matched reference range;
• Systolic Blood Pressure \< 160 mmHg and ≥ 140 mmHg or Diastolic BP \< 100 mmHg ≥ 90mmHg;
• Signed informed consent.

You may not qualify if:

• 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；
• History of major cardiovascular or cerebrovascular events, including myocardial infarction, angina, stroke, or hospitalization for arterial revascularization；
• Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg；
• Diagnosis of malignant tumor；
• Known allergy or history of severe adverse reactions to Coenzyme I injection or any of its components；
• History of severe allergies or infusion reactions；
• Women who are pregnant, breastfeeding, or planning pregnancy；
• Severe hepatic or renal dysfunction: ALT or AST \> 5 times the upper limit of normal; glomerular filtration rate ≤ 30 mL/min/1.73 m²；
• Concurrent participation in another clinical trial without completion of the follow-up period；

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

NAD; Injections

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yi Zhang

CONTACT

18917686332; yizshcn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior doctor, Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 8, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

CN (1)