Kansas University DHA Outcome Study (KUDOS) Follow-Up
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
研究概览
简要总结
This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
详细描述
Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)
- •Agree to consume study capsules from enrollment until delivery
- •Agree to return to the study center for delivery
- •BMI < 40
- •No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)
- •Available by telephone
排除标准
- •Less than 16 or greater than 35 years of age
- •BMI < 40
- •Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive
- •Expecting multiple infants
- •Diabetes or gestational diabetes at baseline
- •Elevated blood pressure due to any cause
- •Not planning to return to the study center for delivery
- •Gestational age at baseline < 8 weeks or >20 weeks
- •Unable or unwilling to agree to consume capsules until delivery
- •Unable to provide informed consent in English
研究组 & 干预措施
DHA Capsule
干预措施: DHA (Drug)
Placebo Capsule
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
时间窗: 72 Months
The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
Cognitive Function Score - Peabody Picture Vocabulary Test
时间窗: 60 Months
The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Cognitive Function Score - Test of Preschool Early Literacy
时间窗: 42 Months
The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
时间窗: 72 Months
The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
次要结局
- Adaptive Regulation Assessment(72 Months)
研究者
Susan Carlson, PhD
Professor
University of Kansas Medical Center