Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
- Conditions
- Pregnancy
- Interventions
- Dietary Supplement: Omega 3Dietary Supplement: Soy Oil
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 74
Women between 28 - 32 weeks pregnancy who accept participate in the study.
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
- Arm && Interventions
Group Intervention Description Omega-3 Omega 3 2 capsules of omega 3 - 2 times a day Soy oil Soy Oil 2 capsules of soy oil - 2 times a day
- 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