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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Omega 3
* Dietary Supplement: Soy Oil


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulsatility index of fetal ductus arteriosus | 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 | 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) | Will be collected blood before and after 21 days of supplementation with omega 3 | 28 to 32 weeks of pregnancy | 
| Biomarkers of oxidative stress | Will be collected blood before and after 21 days of supplementation with omega 3 | 28 to 32 weeks of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyunsaturated fatty acid, fetal ductus arteriosus, inflammation