Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial.
BACKGROUND
Chronic chagasic cardiomyopathy is an inflammatory disease that occurs in approximately 30% of patients infected by the protozoan Trypanosoma cruzi, and it has a profile of high morbidity and mortality. The worst prognosis and the progression of this cardiomyopathy are associated with an exacerbated immune response and the production of proinflammatory cytokines, which also occur in other cardiomyopathies. Some nutrients, including omega-3 polyunsaturated fatty acids (PUFAs), promote the inhibition and/or stimulation of cytokine production. 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 chagasic cardiomyopathy.


METHODS
This is a parallel, randomized, placebo-controlled, double-blind clinical trial with 40 patients that will be conducted at a reference unit for Chagas disease patients, where the patients will be selected. The study will include patients with chronic chagasic cardiomyopathy who are 18 years of age or older. The exclusion criteria are (a) ongoing diarrheal disease, (b) inflammatory bowel disease, (c) diabetes or other endocrine disease, (d) use of fibrates, niacin, or statins, (e) use of anti-inflammatory drugs, (f) pregnant and lactating women, (g) use of vitamin, mineral, or omega-3 supplementation during the previous 30 days, (h) hospital admission during the study, and (i) other associated cardiomyopathies. 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 (interleukin (IL)-1, IL-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)α, interferon (IFN)γ, and transforming growth factor (TGF)β). Secondary endpoints will be the fasting glucose, lipid, and anthropometric profiles. For statistical analysis, we plan to run either a t test or Wilcoxon test (numerical variables) and Pearson's χ2 or Fisher's exact test (categorical data), as appropriate.


CONCLUSIONS
Evidence suggests that the anti-inflammatory action of omega-3 PUFAs may have beneficial effects on chronic chagasic cardiomyopathy, as shown for other cardiomyopathies, due to improved control of the inflammatory response. At the end of the study, we predict that patients will have lower inflammatory markers and an improved metabolic and anthropometric profile.


BACKGROUND
Current Controlled Trials NCT01863576.
Serviço de Nutrição, Instituto de Pesquisa Clínica Evandro Chagas, Fundação Oswaldo Cruz, Av, Brasil 4365, Manguinhos, Rio de Janeiro, Brasil. paula.simplicio@ipec.fiocruz.br.
Paula S
PS
Silva
Gilberto Marcelo
GM
Sperandio da Silva
Andréa P
AP
de Souza
Claudia S A
CS
Cardoso
Cristiane A
CA
Fonseca
Patricia D
PD
Brito
Roberto M
RM
Saraiva
Pedro E A
PE
Brasil
Roberta O
RO
Pinheiro
Alejandro M
AM
Hasslocher-Moreno
Sérgio S
SS
Xavier
Andréa S
AS
Sousa
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001938:Brazil; D002598:Chagas Cardiomyopathy / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D016009:Chi-Square Distribution; D002908:Chronic Disease; D002985:Clinical Protocols; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D018836:Inflammation Mediators / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D015596:Nutrition Assessment; D009752:Nutritional Status; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D015525:Fatty Acids, Omega-3; D018836:Inflammation Mediators; D008055:Lipids