Status:
COMPLETED
The Use of L-arginine to Mitigate the Cardiovascular Effects of Exposure to Traffic-related Air Pollution
Lead Sponsor:
Peking University
Conditions:
Blood Pressure
Cardiac Ischemia
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
The present study is aimed to investigate whether oral L-arginine supplementation reduces the adverse cardiovascular effects of exposure to traffic-related air pollution among a group of non-smoking a...
Detailed Description
The present study is designed as a randomized, double-blind, placebo-controlled trial of L-arginine (L-Arg, a precursor of nitric oxide in human body) supplement to counteract the acute cardiovascular...
Eligibility Criteria
Inclusion
- Having elevated systolic blood pressure between 120-160 mmHg, and diastolic blood pressure between 65-100 mmHg, either with or without routine antihypertensive medications.
- Adults between 50 and 75 years of age, current non-smokers;
- Do not take routine vasoactive dietary supplements.
Exclusion
- Hypertension with SBP\>160 mmHg or DBP\>100 mmHg, clinical diagnosis of cardiovascular disease (excluding hypertension), or other important chronic diseases such as coagulopathy, chronic obstructive pulmonary disease, asthma, gastrointestinal diseases, cancer or mental diseases;
- No routine use of vasoactive dietary supplements,or, if taking, willing to forego their use during the trial.
- Fasting LDL cholesterol≥4.92 mmol/L or total cholesterol≥6.21 mmol/L or HbA1c\>9%;
- Liver or renal dysfunction;
- Acute coronary symptoms or unstable clinical manifestations within the past three months;
- Suffering from allergic diseases/known allergy to ingredients of L-Arg; or those who suffered from acute illness before start of the study;
- Alcohol or drug addiction;
- Hepatitis B / hepatitis C virus patient / carrier;
- History of organ transplants or major surgery in the past year;
- Exposed to occupational sources of air pollution;
- Unwilling or unable to provide informed consent or cooperate with all research related procedures.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03433963
Start Date
January 2 2018
End Date
March 31 2020
Last Update
March 10 2021
Active Locations (3)
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1
Qinglongqiao Community Health Service Center
Beijing, China, 100091
2
Malianwa Community Health Service Center
Beijing, China, 100191
3
Shangdi Community Health Service Center
Beijing, China, 100191