Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
Effects of Omega-3 Polyunsaturated Fatty Acid Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy: a Randomized Controlled Clinical Trial
1 other identifier
interventional
40
1 country
1
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: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Mar 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 9, 2016
September 1, 2016
10 months
May 22, 2013
September 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cytokine profile
The primary endpoint of this study will be the cytokine profile. IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β will be measured in the serum of patients using specific sandwich enzyme-linked immunosorbent assays. Capture and detection antibodies will be obtained from eBioscience (San Diego, CA, USA).
8 weeks
Secondary Outcomes (1)
Lipid profile
8 weeks
Other Outcomes (1)
Anthropometric measures
8 weeks
Study Arms (2)
Omega-3
ACTIVE COMPARATORThis group is receiving omega-3 supplement.
Oil Corn
PLACEBO COMPARATORThis group is receiving the placebo comparator.
Interventions
The group omega-3 receives 5 capsules / day, each capsule containing 1100mg of lipids, and 600 mg of omega-3, 3g of omega-3 per day (1.8 g EPA and 1.2 g DHA) for a period of 8 weeks.
The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evandro Chagas Institute of Clinical Researchlead
- Andrea Silvestre de Sousa, MD PhDcollaborator
- Alejandro Marcel Hasslocher, MD MSc PhD studentcollaborator
- Andrea Pereira de Souza, PhDcollaborator
- Claudia Santos de Aguiar Cardoso, MSccollaborator
- Patricia Dias de Brito, PhDcollaborator
- Pedro Emmanuel Alvarenga Americano do Brasil, MD PhDcollaborator
- Roberta Olmo Pinheiro, PhDcollaborator
- Roberto Magalhães Saraiva, MD PhDcollaborator
- Sergio Salles Xavier, MD PhDcollaborator
- Paula Simplicio da Silva, MSc PhD studentcollaborator
Study Sites (1)
Evandro Chagas Institute of Clinical Research
Rio de Janeiro, Br|rj, 21040-360, Brazil
Related Publications (2)
Silva PSD, Mediano MFF, Silva GMSD, Brito PD, Cardoso CSA, Almeida CF, Sangenis LHC, Pinheiro RO, Hasslocher-Moreno AM, Brasil PEAAD, Sousa AS. Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study. Nutr J. 2017 Jun 9;16(1):36. doi: 10.1186/s12937-017-0259-0.
PMID: 28599665DERIVEDSilva PS, Sperandio da Silva GM, de Souza AP, Cardoso CS, Fonseca CA, Brito PD, Saraiva RM, Brasil PE, Pinheiro RO, Hasslocher-Moreno AM, Xavier SS, Sousa AS. 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. doi: 10.1186/1745-6215-14-379.
PMID: 24216069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrea S Sousa, MD PhD
Evandro Chagas Institute of Clinical Research
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 22, 2013
First Posted
May 29, 2013
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
December 1, 2015
Last Updated
September 9, 2016
Record last verified: 2016-09