Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health (DHA-2)
2014年9月17日 更新者：Children's Hospital Medical Center, Cincinnati
Docosahexaenoic Acid Supplementation of Women With Hypertension in Pregnancy to Improve Endothelial Health and Reduce the Risks of Preterm Delivery
The Investigator would like to see if taking a DHA supplement at a dose recommended for heart health will improve brachial artery dilation (relaxation) and help blood pressure.
As a second goal the Investigator would like to see if this supplement can delay preterm delivery by improving heart health.
In this research study, the Investigator is asking pregnant women with chronic high blood pressure to take Expecta (DHA - Martek Biosciences, now known as DSM Nutritional Lipil) during the last half of their pregnancy until six weeks after they deliver their baby.
研究概览
详细说明
The Investigator will be supplementing pregnant mothers with Expecta.
This is an over the counter supplement often used by pregnant and nursing mothers and will be given to expectant mothers during the research study.
This DHA supplement is available to anyone at most any store.
The dose often used over the counter is 200mg, we are testing the heart recommended dose of 1000mg.
Because the Investigator is using the heart health recommended dose and because there may be a health claim, the Investigator is doing the study using an FDA- food and drug administration IND.
IND means investigational drug.
This dose has recently been used safely and effectively in pregnancy both here in the United States and in Australia in hundreds of women.
There are no risks to the fetus as the placenta prefers to transfer this important nutrient for fetal eye and brain development.
The large studies done in pregnancy have followed their babies into school age and found no adverse effects.
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ohio
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Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Pregnant women coming for their 19-20 week ultrasound for fetal anatomy and that have been diagnosed with hypertension by their Obstetrician will be eligible for inclusion.
Exclusion Criteria:
- Exclusions to enrollment will include: women < 18 years old
- Bleeding disorders
- Lupus
- Autoimmune diseases
- The presence of infant congenital (trisomy 13,18, 21, urethral, gastrointestinal and cardiac defects)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：200 mg docosahexaenoic acid
Participants will be randomized to 200 mg of docosahexaenoic acid (DHA) administered PO daily (1-200mg capsule of DHA).
This is a standard dose used in prenatal vitamins.
Participants will be supplemented by mouth daily between 18-20 weeks gestation through 6 weeks post-partum.
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Participants will be randomized to 200 mg docosahexaenoic acid daily (1-200mg capsule) PO beginning at 18-20 weeks gestation through 6 weeks post-partum.
其他名称：
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有源比较器：1000 mg docosahexaenoic acid
Participants will be randomized to 1000 mg of docosahexaenoic acid (DHA) administered PO daily (5- 200mg capsules of DHA).
Participants will be supplemented daily PO between 18-20 weeks gestation through 6 weeks post-partum.
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Participants will be randomized to 1000 mg (5-200mg capsules) docosahexaenoic acid PO daily beginning at 18-20 weeks gestation through 6 weeks post-partum.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improve maternal endothelial health
大体时间：Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum
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To test this hypothesis, the Investigator will undertake a RCT of 90 women with hypertension (chronic or newly diagnosed) in the second trimester of pregnancy, who will be randomized to 1000mg DHA or standard supplement and followed through to delivery with serial measures of blood pressure and vascular constriction by the Doppler method.
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Pregnant mothers 18-20 weeks gestation (Baseline) - Six weeks post partum
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improve immune homeostasis
大体时间：Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
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Measured by decreased maternal blood and cord blood concentrations of pro-inflammatory cytokines IL-6, I L-8, TNF a, and receptor sRAGE.
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Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Decrease the number of infants born <34 weeks
大体时间：Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
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In addition to the primary aims, we will examine evidence that DHA will prolong gestation
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Pregnant mothers 18-20 weeks gestation (Baseline) through 6 weeks post partum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christina J Valentine, MD, MS, RD、Cincinnati Children's Hosptial Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年12月1日
初级完成 (预期的)
2015年11月1日
研究完成 (预期的)
2016年4月1日
研究注册日期
首次提交
2014年5月12日
首先提交符合 QC 标准的
2014年5月12日
首次发布 (估计)
2014年5月13日
研究记录更新
最后更新发布 (估计)
2014年9月18日
上次提交的符合 QC 标准的更新
2014年9月17日
最后验证
2014年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 2013-7329
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.