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Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial.
Trials. 2013 Nov 11; 14:379.T

Abstract

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/DESIGN

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.

DISCUSSION

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.

TRIAL REGISTRATION

Current Controlled Trials NCT01863576.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24216069

Citation

Silva, Paula S., et al. "Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation in Patients With Chronic Chagasic Cardiomyopathy: Study Protocol for a Randomized Controlled Trial." Trials, vol. 14, 2013, p. 379.
Silva PS, Sperandio da Silva GM, de Souza AP, et al. Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial. Trials. 2013;14:379.
Silva, P. S., Sperandio da Silva, G. M., de Souza, A. P., Cardoso, C. S., Fonseca, C. A., Brito, P. D., Saraiva, R. M., Brasil, P. E., Pinheiro, R. O., Hasslocher-Moreno, A. M., Xavier, S. S., & Sousa, A. S. (2013). Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial. Trials, 14, 379. https://doi.org/10.1186/1745-6215-14-379
Silva PS, et al. Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation in Patients With Chronic Chagasic Cardiomyopathy: Study Protocol for a Randomized Controlled Trial. Trials. 2013 Nov 11;14:379. PubMed PMID: 24216069.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial. AU - Silva,Paula S, AU - Sperandio da Silva,Gilberto Marcelo, AU - de Souza,Andréa P, AU - Cardoso,Claudia S A, AU - Fonseca,Cristiane A, AU - Brito,Patricia D, AU - Saraiva,Roberto M, AU - Brasil,Pedro E A, AU - Pinheiro,Roberta O, AU - Hasslocher-Moreno,Alejandro M, AU - Xavier,Sérgio S, AU - Sousa,Andréa S, Y1 - 2013/11/11/ PY - 2013/06/05/received PY - 2013/10/28/accepted PY - 2013/11/13/entrez PY - 2013/11/13/pubmed PY - 2014/9/3/medline SP - 379 EP - 379 JF - Trials JO - Trials VL - 14 N2 - 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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Current Controlled Trials NCT01863576. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/24216069/Effects_of_omega_3_polyunsaturated_fatty_acid_supplementation_in_patients_with_chronic_chagasic_cardiomyopathy:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-379 DB - PRIME DP - Unbound Medicine ER -