Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Pulsatility index of fetal ductus arteriosus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 28 - 32 weeks pregnancy who accept participate in the study.
排除标准
- •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.
研究组 & 干预措施
Soy oil
2 capsules of soy oil - 2 times a day
干预措施: Soy Oil (Dietary Supplement)
Omega-3
2 capsules of omega 3 - 2 times a day
干预措施: Omega 3 (Dietary Supplement)
结局指标
主要结局
Pulsatility index of fetal ductus arteriosus
时间窗: 28 to 32 weeks of pregnancy
The measure will be collected before and after 21 days of supplementation with omega 3 capsules
次要结局
- Biomarkers of oxidative stress(28 to 32 weeks of pregnancy)
- 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)
