PregnancyNCT02565290
Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
A study testing Omega 3 and Soy Oil in people with Pregnancy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Omega 3 and Soy Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
Paulo Zielinsky, Doctor contact
Camila Brum, Master contact
Brazil1 site, 1 recruiting
- Recruiting
Paulo Zielinsky
Porto Alegre, Rio Grande do Sul, 90620-000
Camila Brum, Master, (51) 32303600, andradebrum@gmail.com
Izabele Vian, Master, izabele.nutri@gmail.com
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Omega 3, Soy Oil
- Keywords
- polyunsaturated fatty acid, fetal ductus arteriosus, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Dietary supplement
Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days.
Soy OilDietary supplement
Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Active comparator | 2 capsules of omega 3 - 2 times a day Receives: Dietary Supplement: Omega 3 |
| Soy oil | Placebo comparator | 2 capsules of soy oil - 2 times a day Receives: Dietary Supplement: Soy Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility index of fetal ductus arteriosus
The measure will be collected before and after 21 days of supplementation with omega 3 capsules
Measured: 28 to 32 weeks of pregnancy
Secondary outcomes (3)
Systolic and diastolic velocity of fetal ductus arteriosus
The measure will be collected before and after 21 days of supplementation with omega 3
Measured: 28 to 32 weeks of pregnancy
Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)
Will be collected blood before and after 21 days of supplementation with omega 3
Measured: 28 to 32 weeks of pregnancy
Biomarkers of oxidative stress
Will be collected blood before and after 21 days of supplementation with omega 3
Measured: 28 to 32 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Zielinsky, Doctor, Study director, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565290
- Sponsor's protocol ID
- UP4989/2014
- Status last verified
- Sep 2015
- First submitted
- 30 Sep 2015
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23949325Vian 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.
PubMed 23316751Zielinsky 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.
PubMed 22821626Bubols 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.
PubMed 25043716
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02565290
- Acronym / sponsor ID
- UP4989/2014
- Conditions
- Pregnancy
- Keywords
- polyunsaturated fatty acid, fetal ductus arteriosus, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega 32 capsules of omega 3 - 2 times a day |
| Soy oil | Placebo comparator | Dietary Supplement: Soy Oil2 capsules of soy oil - 2 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days. | Dietary supplement | Omega-3 |
| Soy OilPregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days. | Dietary supplement | Soy oil |
Primary outcome
Pulsatility index of fetal ductus arteriosus
Time frame: 28 to 32 weeks of pregnancy
The measure will be collected before and after 21 days of supplementation with omega 3 capsules
3 secondary outcomes
Systolic and diastolic velocity of fetal ductus arteriosus
Time frame: 28 to 32 weeks of pregnancy
Inflammatory biomarkers (interleukins, prostaglandins, cyclooxygenase)
Time frame: 28 to 32 weeks of pregnancy
Biomarkers of oxidative stress
Time frame: 28 to 32 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Results publication: PubMed 23949325Zielinsky 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.
- Results publication: PubMed 23316751Vian 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.
- Results publication: PubMed 22821626Zielinsky 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.
- Results publication: PubMed 25043716Bubols 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Zielinsky, Doctor contact
Camila Brum, Master contact
Paulo Zielinsky, Doctor study director
Instituto de Cardiologia do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 and Soy Oil in people with Pregnancy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Zielinsky, Doctor (paulozie.voy@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulsatility index of fetal ductus arteriosus (time frame: 28 to 32 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565290, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.