NCT02565290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 30, 2015

Last Update Submit

September 30, 2015

Conditions

Pregnancy

Keywords

polyunsaturated fatty acidfetal ductus arteriosusinflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Systolic and diastolic velocity of fetal ductus arteriosus

    28 to 32 weeks of pregnancy

  • Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)

    28 to 32 weeks of pregnancy

  • Biomarkers of oxidative stress

    28 to 32 weeks of pregnancy

Study Arms (2)

Omega-3

ACTIVE COMPARATOR

2 capsules of omega 3 - 2 times a day

Dietary Supplement: Omega 3

Soy oil

PLACEBO COMPARATOR

2 capsules of soy oil - 2 times a day

Dietary Supplement: Soy Oil

Interventions

Omega 3DIETARY_SUPPLEMENT

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

Omega-3
Soy OilDIETARY_SUPPLEMENT

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

Soy oil

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paulo Zielinsky

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23949325RESULT

  • 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.

    PMID: 23316751RESULT

  • 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.

    PMID: 22821626RESULT

  • 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.

    PMID: 25043716RESULT

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic AcidsSoybean Oil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Paulo Zielinsky, Doctor

    Instituto de Cardiologia do Rio Grande do Sul

    STUDY DIRECTOR

Central Study Contacts

Paulo Zielinsky, Doctor

CONTACT

paulozie.voy@terra.com.br

Camila Brum, Master

CONTACT

andradebrum@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

BR(1)