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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Active Comparator | 2 capsules of omega 3 - 2 times a day |
|
| Soy oil | Placebo Comparator | 2 capsules of soy oil - 2 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 | Dietary Supplement | Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days. |
|
| 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 |
| 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) |
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Inclusion Criteria: Women between 28 - 32 weeks pregnancy who accept participate in the study.
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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.
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulo Zielinsky, Doctor | Contact | paulozie.voy@terra.com.br | ||
| Camila Brum, Master | Contact | andradebrum@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Zielinsky, Doctor | Instituto de Cardiologia do Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paulo Zielinsky | Recruiting | Porto Alegre | Rio Grande do Sul | 90620-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23949325 | Result | Zielinsky P, Piccoli AL Jr, Vian I, Zilio AM, Naujorks AA, Nicoloso LH, Barbisan CW, Busato S, Lopes M, Klein C. Maternal restriction of polyphenols and fetal ductal dynamics in normal pregnancy: an open clinical trial. Arq Bras Cardiol. 2013 Sep;101(3):217-25. doi: 10.5935/abc.20130166. Epub 2013 Aug 14. | |
| 23316751 | Result |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D013024 | Soybean Oil |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Soy Oil | Dietary Supplement | Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days. |
|
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 |
| Vian I, Zielinsky P, Zilio AM, Mello A, Lazzeri B, Oliveira A, Lampert KV, Piccoli A, Nicoloso LH, Bubols GB, Garcia SC. Development and validation of a food frequency questionnaire for consumption of polyphenol-rich foods in pregnant women. Matern Child Nutr. 2015 Oct;11(4):511-24. doi: 10.1111/mcn.12025. Epub 2013 Jan 15. |
| 22821626 | Result | Zielinsky P, Manica JL, Piccoli AL Jr, Nicoloso LH, Barra M, Alievi MM, Vian I, Zilio A, Pizzato PE, Silva JS, Bender LP, Pizzato M, Menezes HS, Garcia SC. Fetal ductal constriction caused by maternal ingestion of green tea in late pregnancy: an experimental study. Prenat Diagn. 2012 Oct;32(10):921-6. doi: 10.1002/pd.3933. Epub 2012 Jul 23. |
| 25043716 | Result | Bubols GB, Zielinsky P, Piccoli AL Jr, Nicoloso LH, Vian I, Moro AM, Charao MF, Brucker N, Bulcao RP, Nascimento SN, Baierle M, Alievi MM, Moresco RN, Markoski M, Garcia SC. Nitric oxide and reactive species are modulated in the polyphenol-induced ductus arteriosus constriction in pregnant sheep. Prenat Diagn. 2014 Dec;34(13):1268-76. doi: 10.1002/pd.4463. Epub 2014 Aug 22. |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |