Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Ch… (NCT01863576) | Clinical Trial Compass
CompletedEarly Phase 1
Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Brazil40 participantsStarted 2013-03
Plain-language summary
The objective of this trial is to study the effects of omega-3 PUFA supplementation on the inflammatory response and lipid profile in patients with chronic Chagas cardiomyopathy.
Study Type: Interventional
Study Design: A total 40 patients will be randomly assigned into two parallel groups. The intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks, compared to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory markers (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Secondary endpoints will be the fasting glucose, lipid, and anthropometric profiles.
Who can participate
Age range
18 Years – 85 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:
* Volunteers with Chagas Cardiomyopathy at stage B (no heart failure symptoms but with segmental or global left ventricular systolic dysfunction), stage C (symptomatic heart failure), or stage D (end-stage heart failure)), according to the current Brazilian Chagas' Disease Consensus;
* Subjects will include adults, men and women.
Exclusion Criteria:
* diarrheal disease;
* inflammatory bowel syndrome;
* diagnosis of diabetes or other endocrine pathologies;
* use of fibrates, niacin, or statins;
* use of anti-inflammatory drugs;
* pregnant and lactating women;
* vitamin mineral or omega-3 supplementation during the previous 30 days;
* hospital admission during the study;
* presence of cardiomyopathies other than Chagas Cardiomyopathy.
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
Cytokine profile
Timeframe: 8 weeks
Trial details
NCT IDNCT01863576
SponsorEvandro Chagas Institute of Clinical Research