Effect of a Non-pharmacological Intervention on Endothelial Function, Body Composition, and Physi… (NCT07544186) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Non-pharmacological Intervention on Endothelial Function, Body Composition, and Physical Functionality in Recovered COVID-19 Patients.
Mexico43 participantsStarted 2020-11-09
Plain-language summary
This study aims to evaluate the impact of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical functionality in recovered COVID-19 patients.
The primary research question is: What is the effect of a non-pharmacological treatment (nutritional therapy and pulmonary rehabilitation) on endothelial function, body composition, and physical capacity in recovered COVID-19 patients, compared to those receiving conventional medical management? A nutritional treatment combined with L-citrulline supplementation (intervention group) will be compared against conventional treatment alone (control group). Both groups will undergo pulmonary rehabilitation for a 3-month follow-up.
Subjects assigned to the intervention group will be required to:
* Take 4 g of L-citrulline daily for 3 months.
* Attend an interim session at 1.5 months for review of the nutritional treatment and supplementation.
* Keep a record of each supplement intake.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Recovered COVID-19 patients with a negative PCR test for SARS-CoV-2.
* Subjects between 40 and 80 years.
* Subjects who give written informed consent to participate in the study.
Exclusion Criteria:
* Subjects diagnosed with Human Immunodeficiency Virus (HIV).
* Subjects diagnosed with cancer.
* Subjects with a glomerular filtration rate (GFR) \<30 ml/min/1.73 m².
* Subjects currently enrolled in another interventional study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Endothelial disfunction markers
Timeframe: 3 months
2
Body composition
Timeframe: 3 months
3
Physical functionality
Timeframe: 3 months
Trial details
NCT IDNCT07544186
SponsorInstituto Nacional de Enfermedades Respiratorias