| Registry | NCT02565290 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: triple |
| Enrollment | 74 (Estimated) |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul (Other) |
| Conditions | Pregnancy |
| Interventions | Omega 3, Soy Oil (Dietary supplement) |
| Dates | start 2015-05-01, primary completion 2016-05-01 (estimated), completion 2016-06-01 (estimated), first posted 2015-10-01, last updated 2015-10-01 |
| Locations | 1 site in Brazil |
Related Papers Related Patents Related Grants Related Experts
All trials for Pregnancy All trials of Omega 3 All trials of Soy Oil
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Omega-3 | Active comparator | Dietary Supplement: Omega 3 | 2 capsules of omega 3 - 2 times a day |
| Soy oil | Placebo comparator | Dietary Supplement: Soy Oil | 2 capsules of soy oil - 2 times a day |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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. \-
| Facility | City | Country | Status |
|---|---|---|---|
| Paulo Zielinsky | Porto Alegre, Rio Grande do Sul | Brazil | Recruiting |