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临床试验/NCT00620672
NCT00620672已完成1 期

To Compare Measures of Central Nervous System Maturity of Visual Acuity, Language, Mental and Motor Skill Development in Term Infants Following Maternal Supplementation Wit the n-3 Fatty Acid Docosahexaenoic Acid (DHA) During Gestation.

University of British Columbia2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
270
试验地点
2
主要终点
Primary outcome is measuring of infant CNS maturity to 18 months of age

研究概览

简要总结

Polyunsaturated fatty acids known as n-3 fatty acids are essential dietary nutrients for humans, and are known to be important to reducing the risk of certain diseases, particularly those related to neural system, cardiovascular system and immune system. Among the different n-3 fatty acids, docosahexaenoic acid (DHA) is present in particularly high amounts in the brain and retina, and is accumulated in large amounts in these organs during the last trimester of fetal development and first few months after birth. The n-3 fatty acids are present in the diet as linolenic acid which is found in vegetable and seed oils, and as DHA which is only found in animal tissue fats, with fatty fish being the richest dietary source. Humans are able to convert linolenic acid to DHA, but the conversion is believed to be slow in human and possibly inadequate to support the needs for DHA for the developing brain. Information from our work and those of others has suggested that DHA is important during pregnancy, however specific evidence is lacking to show that the DHA status of pregnant women in low, or that improvement in the DHA status of Canadian women during pregnancy will have benefit to early infant an child development. There is no evidence that infants of vegans and vegetarians, or women who do not eat DHA are at risk for developmental delays. The purpose of this study is to investigate whether a dietary supplement of DHA during pregnancy has any effect on infant birth weight, or indices of infant growth, visual, mental and motor skill development.

详细描述

This is a randomized, blinded prospective study with 2 groups: placebo and group supplemented with DHA. Women are randomized at 16 weeks gestation without knowledge of their dietary fatty acid intake. Only healthy women expecting to deliver a single infant with no known or anticipated maternal or fetal complications are enrolled. Maternal venous blood is collected at 16 and 36 weeks of gestation and used to assess the maternal DHA status and effect of DHA supplementation. Dietary information is collected at 16 and 36 weeks of gestation to determine usual fatty acid intakes. Following delivery, fetal cord blood is collected to assess transfer of DHA from mother to fetus. Breast milk samples are collected from all breast feeding mothers at 1 and 2 months postpartum. The mother -infant pairs are followed for 18 months. Measures include visual acuity, language, motor and mental development, and growth and dietary intakes.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 12-16 weeks gestation
  • Low risk pregnancy
  • Expected to deliver single full term
  • No maternal metabolic or infectious disease
  • No known fetal complications.

排除标准

  • 未提供

结局指标

主要结局

Primary outcome is measuring of infant CNS maturity to 18 months of age

时间窗: 18 months

Primary outcome is measuring of infant CNS maturity to 18 months of age

次要结局

  • Length of gestation and infant birth weight, infant growth (weight, length and head circumference) at 1,2 6,9,12,14,and 18 months Language development at 14 and 16 months(72 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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