Clinical trial NCT02565290: Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
Official title: Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: polyunsaturated fatty acid
fetal ductus arteriosus
inflammation
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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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Primary outcomes:
measure: Pulsatility index of fetal ductus arteriosus
timeFrame: 28 to 32 weeks of pregnancy
Secondary outcomes:
measure: Systolic and diastolic velocity of fetal ductus arteriosus
timeFrame: 28 to 32 weeks of pregnancy
measure: Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)
timeFrame: 28 to 32 weeks of pregnancy
measure: Biomarkers of oxidative stress
timeFrame: 28 to 32 weeks of pregnancy
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Paulo Zielinsky
state: RS
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul
name: Paulo Zielinsky, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.