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 range18 Years – 85 Years

SexALL

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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.

What they're measuring

Cytokine profile

Timeframe: 8 weeks

Trial details

NCT IDNCT01863576

SponsorEvandro Chagas Institute of Clinical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01