Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.

September 30, 2015 updated by: Instituto de Cardiologia do Rio Grande do Sul
The effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3 about changing this dynamic is not established. This study evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. Women with gestational between 28 to 32 weeks will receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The omega-3 features similar the statins to be antioxidants and anti-inflammatory drugs and their derivatives have the function of slowing the neuro-inflammation, oxidative stress and apoptotic cell death anti-inflammatory properties. Also, they have antithrombotic effects, being related to prevent disease. Studies show that supplementation with omega-3 has a positive impact on several outcomes like cardiovascular disease, asthma, rheumatoid arthritis and Alzehimer. Objective: Evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. Methodology: randomized double blind clinical trial. Women with gestational age between 28 to 32 weeks, literate, over 18 years will be invited. Pregnant women with anti-inflammatory drugs, they have a higher intake of dietary polyphenols to 127mg / day or using drugs that may interfere with the absorption of omega-3 are excluded. The selected women will be randomized to receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks. In the first interview, and after 3 weeks, they will respond the Questionnaire Food Frequency (QFF) to quantify polyphenols and omega 3 in their diet, weight and height will be measured and the examination of fetal echocardiography is performed.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90620-000
        • Recruiting
        • Paulo Zielinsky
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paulo Zielinsky, Doctor
        • Principal Investigator:
          • Camila Brum, Master
        • Principal Investigator:
          • Izabele Vian, Master
        • Sub-Investigator:
          • Antônio Piccoli, Doctor
        • Sub-Investigator:
          • Luis Henrique Nicoloso, Doctor
        • Sub-Investigator:
          • Melissa Markoski, PHD
        • Sub-Investigator:
          • Ana Maria Zilio, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria: Women between 28 - 32 weeks pregnancy who accept participate in the study.

-

Exclusion Criteria: hypertensive , diabetic , who use anti-inflammatory drugs , HIV positive , do not take mate, black or green tea, had inflammation in the last 5 days, allergic to fish or soy.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omega-3
2 capsules of omega 3 - 2 times a day
Dietary supplement: Omega 3
Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days.
Placebo Comparator: Soy oil
2 capsules of soy oil - 2 times a day
Dietary supplement: Soy Oil
Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulsatility index of fetal ductus arteriosus
Time Frame: 28 to 32 weeks of pregnancy
The measure will be collected before and after 21 days of supplementation with omega 3 capsules
28 to 32 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic velocity of fetal ductus arteriosus
Time Frame: 28 to 32 weeks of pregnancy
The measure will be collected before and after 21 days of supplementation with omega 3
28 to 32 weeks of pregnancy
Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)
Time Frame: 28 to 32 weeks of pregnancy
Will be collected blood before and after 21 days of supplementation with omega 3
28 to 32 weeks of pregnancy
Biomarkers of oxidative stress
Time Frame: 28 to 32 weeks of pregnancy
Will be collected blood before and after 21 days of supplementation with omega 3
28 to 32 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Investigators

  • Study Director: Paulo Zielinsky, Doctor, Instituto de Cardiologia do Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP4989/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on Omega 3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe