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临床试验/NCT00672230
NCT00672230已完成不适用

The Placental and Mammary Transfer of Lutein and Zeaxanthin Into the Fetus and the Breast-fed Infant

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2005年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
2
主要终点
Breast milk lutein, mcg/dL

研究概览

简要总结

The clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

详细描述

About one-fourth of preterm infants who weight less than 2 3/4 pounds at birth develop an eye problem. This problem occurs in the retina (back of the eye) and may result in blindness. This eye problem is called the retinopathy of prematurity(ROP). There are two yellow pigments in the retina called lutein and zeaxanthin. These pigments may protect the retina from being damaged by light. They may also protect the retina from being damaged by oxygen. These pigments are transferred from the mother to the baby. Most of this takes place during the last trimester of pregnancy. The situation could be worse if the baby receives formula. Most baby formulas do not contain lutein and zeaxanthin; breast milk does. Another worry is that breast milk may not have enough lutein and zeaxanthin if the mother does not eat enough vegetables and fruits. The purpose of this study is to measure the transfer of lutein and zeaxanthin from the mother to the baby, to measure the amount of lutein and zeaxanthin in breast milk, to find out if taking a lutein supplement will increase the amount of lutein in breast milk and to find out if dietary lutein and zeaxanthin are involved in the development of the retinopathy of prematurity (ROP).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Planning to breast feed for at least 12 weeks
  • Willing to be randomized to take the lutein supplement

排除标准

  • Insufficient quantity of breast milk

研究组 & 干预措施

Lut Supp

Experimental

干预措施: Lutein supplement (Dietary Supplement)

结局指标

主要结局

Breast milk lutein, mcg/dL

时间窗: 4 weeks

次要结局

  • Plasma Lutein, mcg/dL(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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