Status:
COMPLETED
Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Lead Sponsor:
Evandro Chagas Institute of Clinical Research
Collaborating Sponsors:
Andrea Silvestre de Sousa, MD PhD
Alejandro Marcel Hasslocher, MD MSc PhD student
Conditions:
Chagas Cardiomyopathy
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief 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: Interven...
Detailed Description
Several studies have shown the beneficial effects of polyunsaturated fatty acids on inflammatory processes, dyslipidemia, and cardiovascular diseases, there are no reports about food intake and PUFA s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01863576
Start Date
March 1 2013
End Date
December 1 2015
Last Update
September 9 2016
Active Locations (1)
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1
Evandro Chagas Institute of Clinical Research
Rio de Janeiro, Br|rj, Brazil, 21040-360