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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565290
• Other study ID #: UP4989/2014
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: September 30, 2015
• Start date: May 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Paulo Zielinsky, Doctor
• Email: paulozie.voy[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Pregnancy

Intervention

Dietary Supplement:
• Omega 3
Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days.
• Soy Oil
Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days.

Locations

Country	Name	City	State
Brazil	Paulo Zielinsky	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Bubols GB, Zielinsky P, Piccoli AL Jr, Nicoloso LH, Vian I, Moro AM, Charão MF, Brucker N, Bulcão 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 — View 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 — View 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 experimen — View Citation

Zielinsky P, Piccoli AL Jr, Vian I, Zílio 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):2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Biomarkers of oxidative stress	Will be collected blood before and after 21 days of supplementation with omega 3	28 to 32 weeks of pregnancy	Yes