Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 3
- 主要终点
- Occurrence of Early Preterm Birth (<34 weeks gestation)
研究概览
简要总结
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
详细描述
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
- •Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- •Available by telephone
- •Able to speak and read in either English or Spanish language
排除标准
- •Expecting multiple infants
- •Gestational age at baseline <12 weeks or >20 weeks
- •Unable or unwilling to agree to consume capsules until delivery
- •Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day
- •Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
研究组 & 干预措施
200 mg/day DHA
Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.
干预措施: Docosahexaenoic acid - 200mg/day (Drug)
200 mg/day DHA
Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.
干预措施: Placebo (Other)
1000 mg/day DHA
The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.
干预措施: Docosahexaenoic acid - 800mg/day (Drug)
1000 mg/day DHA
The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.
干预措施: Docosahexaenoic acid - 200mg/day (Drug)
结局指标
主要结局
Occurrence of Early Preterm Birth (<34 weeks gestation)
时间窗: Baseline to 34 weeks
Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)
Maternal and infant adverse and serious adverse events
时间窗: Enrollment to 30 days past last birth
Bayesian posterior mean and 95% credible interval by dose
次要结局
- Admissiion of neonate to a neonatal intensive care unit(birth)
- Very low birth weight(At birth)
- Preterm birth (<37 weeks)(birth)
- Pre-eclampsia(12-20 weeks gestation through birth at an average of 40 weeks)
- Cesarean section(birth)
- Maternal and infant DHA status(birth)
- Spontaneous labor(birth)
- Low birth weight(birth)
- Gestational age(birth)
- Birth weight(birth)
- Length and head circumference(birth)
- Gestational diabetes(12-20 weeks gestation through birth at an average of 40 weeks)
研究者
Susan Carlson, PhD
Professor, Dietetics and Nutrition
University of Kansas Medical Center