Chagas CardiomyopathyEarly Phase 1NCT01863576
Effects of Omega-3 Supplementation on the Cytokine and Lipid Profiles in Patients With Chronic Chagas Cardiomyopathy
A Early Phase 1 study testing Omega-3 in people with Chagas Cardiomyopathy, run by Evandro Chagas Institute of Clinical Research at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chagas Cardiomyopathy
- What is being tested?
- Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Dec 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- vitamin mineral or omega-3 supplementation during the previous 30 days;
- hospital admission during the study;
- presence of cardiomyopathies other than Chagas Cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Evandro Chagas Institute of Clinical Research
Rio de Janeiro, Br|rj, 21040-360
About this study
Official title: 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
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.
Read the 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 supplementation in chronic Chagas cardiomyopathy patients. Thus, the objective of this study is to assess the effects of omega-3 PUFA supplementation on the lipid profile and the pro-inflammatory and anti-inflammatory cytokine profiles in chronic Chagas cardiomyopathy patients.
After patients are selected by cardiologists, they will be seen by study nutritionists, who will explain the study procedures to the patients and administer the free and informed consent form. The patients who agree to participate in the study will sign the consent form and undergo the initial assessment.
The following data will be collected and evaluated in the study: sociodemographic data (age, sex, ethnicity/race, education, and domicile), clinical data (functional class and vital signs), alcoholism, smoking, prescription drugs, 3-day food record, 24-hour recall, anthropometric assessment (height, weight, BMI, waist circumference, tricipital skinfold thickness, and arm circumference), lipid profile (total cholesterol, triglycerides, HDL-c, LDL-c, and VLDL-c), and cytokines (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Clinical, nutritional, and anthropometric assessments will take place immediately before starting the intervention and after 4 and 8 weeks during the study; lipid profile and cytokines will be evaluated before the intervention and at the end of 8 weeks. Each patient will be followed for 8 weeks.
- Conditions
- Chagas Cardiomyopathy
- Being tested
- Omega-3, Placebo Comparator
- Keywords
- Chagas disease, Chagas Cardiomyopathy, Trypanosoma cruzi, Omega-3, Cytokines, Lipid profile, Nutritional assessment
- Medical subject headings
- Chagas Cardiomyopathy, Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Also called Oil fish, omega 3 fatty acids, polyunsaturated fatty acids
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.
Placebo ComparatorDietary supplement
Also called Oil Corn
The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | This group is receiving omega-3 supplement. Receives: Dietary Supplement: Omega-3 |
| Oil Corn | Placebo comparator | This group is receiving the placebo comparator. Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (1)
Lipid profile
Total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-c) will be measured with enzymatic-colorimetric assays using Siemens reagents on a Siemens Dimension RXL chemistry analyzer (Siemens Healthcare Diagnostics, Tarrytown, NY, USA). Low-density lipoprotein cholesterol (LDL-c) and VLDL-c will be calculated according to the Friedewald equation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chagas CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evandro Chagas Institute of Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Andrea Silvestre de Sousa, MD PhD, Alejandro Marcel Hasslocher, MD MSc PhD student, Andrea Pereira de Souza, PhD, Claudia Santos de Aguiar Cardoso, MSc, Patricia Dias de Brito, PhD, Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD, Roberta Olmo Pinheiro, PhD, Roberto Magalhães Saraiva, MD PhD, Sergio Salles Xavier, MD PhD, Paula Simplicio da Silva, MSc PhD student
- Responsible party
- Principal investigator, Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
- Investigators
- Andrea S Sousa, MD PhD, Study director, Evandro Chagas Institute of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863576
- Sponsor's protocol ID
- 0037.0.009.000-10
- Status last verified
- Sep 2016
- First submitted
- 22 May 2013
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28599665Silva 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.
PubMed 24216069
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01863576
- Acronym / sponsor ID
- 0037.0.009.000-10
- Conditions
- Chagas Cardiomyopathy
- Keywords
- Chagas disease, Chagas Cardiomyopathy, Trypanosoma cruzi, Omega-3, Cytokines, Lipid profile, Nutritional assessment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Evandro Chagas Institute of Clinical ResearchUniversity, hospital or other
- Collaborators
- Andrea Silvestre de Sousa, MD PhD, Alejandro Marcel Hasslocher, MD MSc PhD student, Andrea Pereira de Souza, PhD, Claudia Santos de Aguiar Cardoso, MSc, Patricia Dias de Brito, PhD, Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD, Roberta Olmo Pinheiro, PhD, Roberto Magalhães Saraiva, MD PhD, Sergio Salles Xavier, MD PhD, Paula Simplicio da Silva, MSc PhD student
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 supplementation in chronic Chagas cardiomyopathy patients. Thus, the objective of this study is to assess the effects of omega-3 PUFA supplementation on the lipid profile and the pro-inflammatory and anti-inflammatory cytokine profiles in chronic Chagas cardiomyopathy patients.
After patients are selected by cardiologists, they will be seen by study nutritionists, who will explain the study procedures to the patients and administer the free and informed consent form. The patients who agree to participate in the study will sign the consent form and undergo the initial assessment.
The following data will be collected and evaluated in the study: sociodemographic data (age, sex, ethnicity/race, education, and domicile), clinical data (functional class and vital signs), alcoholism, smoking, prescription drugs, 3-day food record, 24-hour recall, anthropometric assessment (height, weight, BMI, waist circumference, tricipital skinfold thickness, and arm circumference), lipid profile (total cholesterol, triglycerides, HDL-c, LDL-c, and VLDL-c), and cytokines (IL-1, IL-2, IL-4, IL-6, IL-10, TNF-alpha, IFN-γ, and TGF-β). Clinical, nutritional, and anthropometric assessments will take place immediately before starting the intervention and after 4 and 8 weeks during the study; lipid profile and cytokines will be evaluated before the intervention and at the end of 8 weeks. Each patient will be followed for 8 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega-3This group is receiving omega-3 supplement. |
| Oil Corn | Placebo comparator | Dietary Supplement: Placebo ComparatorThis group is receiving the placebo comparator. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- diarrheal disease;
- inflammatory bowel syndrome;
- diagnosis of diabetes or other endocrine pathologies;
- use of fibrates, niacin, or statins;
- use of anti-inflammatory drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3Also: Oil fish, omega 3 fatty acids, polyunsaturated fatty acidsThe 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 | Omega-3 |
| Placebo ComparatorAlso: Oil CornThe group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks. | Dietary supplement | Oil Corn |
Primary outcome
Cytokine profile
Time frame: 8 weeks
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).
1 secondary outcome
Lipid profile
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Derived from this study: PubMed 28599665Silva 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.
- Derived from this study: PubMed 24216069Silva 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.
Related trials for Chagas Cardiomyopathy
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea S Sousa, MD PhD study director
Evandro Chagas Institute of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Omega-3 in people with Chagas Cardiomyopathy, run by Evandro Chagas Institute of Clinical Research at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine profile (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.