Vascular AgingNCT07328100
Efficacy and Safety of Coenzyme I for Injection on Vascular Aging.
A study testing Coenzyme I for Injection in people with Vascular Aging and NAD, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Vascular Aging, NAD
- What is being tested?
- Coenzyme I for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
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- 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；
- Other conditions deemed by the investigator as unsuitable for inclusion, such as psychiatric or psychological disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Vascular Aging, NAD
- Being tested
- Coenzyme I for Injection, NaCl (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme I for InjectionDrug
Subjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection.
NaCl (placebo)Drug
Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Drug: Coenzyme I for Injection |
| Control Group | Placebo comparator | Not described Receives: Drug: NaCl (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in flow-mediated vasodilation(FMD)
Changes in FMD from baseline to day 8/28.
Measured: Day 8/28
Secondary outcomes (6)
Changes in cf-PWV.
Changes in cf-PWV from baseline to day 8/28.
Measured: 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.
Measured: day 8/28
Changes in the level of NAD+
Changes in the level of NAD+ from baseline to day 8/28.
Measured: day 8/28
Changes in the metabolomics.
Changes in the metabolomics from baseline to day 8/28.
Measured: 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.
Measured: 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.
Measured: day 8/28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start16 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328100
- Sponsor's protocol ID
- NAD-VA
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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）
- ClinicalTrials.gov ID
- NCT07328100
- Acronym / sponsor ID
- NAD-VA
- Conditions
- Vascular Aging, NAD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 16 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Coenzyme I for Injection |
| Control Group | Placebo comparator | Drug: NaCl (placebo) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme I for InjectionSubjects receive 7 consecutive days of intravenous infusion of Coenzyme I for injection. | Drug | Intervention Group |
| NaCl (placebo)Subjects receive 7 consecutive days of intravenous infusion of NaCl(0.9%). | Drug | Control Group |
Primary outcome
The change in flow-mediated vasodilation(FMD)
Time frame: Day 8/28
Changes in FMD from baseline to day 8/28.
6 secondary outcomes
Changes in cf-PWV.
Time frame: day 8/28
Changes in retinal arteriovenous ratio (AVR) and wall/lumen ratio (WLR)
Time frame: day 8/28
Changes in the level of NAD+
Time frame: day 8/28
Changes in the metabolomics.
Time frame: day 8/28
Changes in office blood pressure and 24-hour ambulatory blood pressure
Time frame: day 8/28
The change in the urine albumin-to-creatinine ratio
Time frame: day 8/28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme I for Injection in people with Vascular Aging and NAD, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in flow-mediated vasodilation(FMD) (time frame: Day 8/28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.