跳至主要内容
临床试验/NCT02565290
NCT02565290Unknown不适用

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

Instituto de Cardiologia do Rio Grande do Sul1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

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

Placebo Comparator

2 capsules of soy oil - 2 times a day

干预措施: Soy Oil (Dietary Supplement)

Omega-3

Active Comparator

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)

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Sponsor

研究点 (1)

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