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

Not Applicable

• Conditions: Pregnancy

• Registration Number: NCT02565290
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

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.

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 Timeline

• Study Start: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Last Update Submitted: 2015-09-30
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pulsatility index of fetal ductus arteriosus	28 to 32 weeks of pregnancy	The measure will be collected before and after 21 days of supplementation with omega 3 capsules

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Paulo Zielinsky; 🇧🇷 Porto Alegre, RS, Brazil