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Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy

NCT01863576 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-09

No results posted yet for this study

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.

Conditions

  • Chagas Cardiomyopathy

Interventions

DIETARY_SUPPLEMENT

Omega-3

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.

DIETARY_SUPPLEMENT

Placebo Comparator

The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.

Sponsors & Collaborators

  • Andrea Silvestre de Sousa, MD PhD

    collaborator UNKNOWN

  • Alejandro Marcel Hasslocher, MD MSc PhD student

    collaborator UNKNOWN

  • Andrea Pereira de Souza, PhD

    collaborator UNKNOWN

  • Claudia Santos de Aguiar Cardoso, MSc

    collaborator UNKNOWN

  • Patricia Dias de Brito, PhD

    collaborator UNKNOWN

  • Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD

    collaborator UNKNOWN

  • Roberta Olmo Pinheiro, PhD

    collaborator UNKNOWN

  • Roberto Magalhães Saraiva, MD PhD

    collaborator UNKNOWN

  • Sergio Salles Xavier, MD PhD

    collaborator UNKNOWN

  • Paula Simplicio da Silva, MSc PhD student

    collaborator UNKNOWN

  • Evandro Chagas Institute of Clinical Research

    lead OTHER

Principal Investigators

  • Andrea S Sousa, MD PhD · Evandro Chagas Institute of Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-01-31
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863576 on ClinicalTrials.gov