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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02565290
Enrollment
74
Registered
2015-10-01
Start date
2015-05-31
Completion date
2016-06-30
Last updated
2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

polyunsaturated fatty acid, fetal ductus arteriosus, inflammation

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.

Interventions

DIETARY_SUPPLEMENTOmega 3

Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days.

DIETARY_SUPPLEMENTSoy Oil

Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days.

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Pulsatility index of fetal ductus arteriosus28 to 32 weeks of pregnancyThe measure will be collected before and after 21 days of supplementation with omega 3 capsules

Secondary

MeasureTime frameDescription
Systolic and diastolic velocity of fetal ductus arteriosus28 to 32 weeks of pregnancyThe measure will be collected before and after 21 days of supplementation with omega 3
Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)28 to 32 weeks of pregnancyWill be collected blood before and after 21 days of supplementation with omega 3
Biomarkers of oxidative stress28 to 32 weeks of pregnancyWill be collected blood before and after 21 days of supplementation with omega 3

Countries

Brazil

Contacts

Primary ContactPaulo Zielinsky, Doctor
paulozie.voy@terra.com.br
Backup ContactCamila Brum, Master
andradebrum@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026