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临床试验/NCT01947426
NCT01947426已完成2 期

Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn

Universidad de Granada2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年4月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Change of Visual Development of newborn

研究概览

简要总结

In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.

详细描述

The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later:

Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control.

Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values.

The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
— 至 40 Years(Child, Adult)
接受健康志愿者

入选标准

  • mother with normal gestation.

排除标准

  • Risk factors during gestation.
  • Lactose intolerance
  • systemic illness.
  • Kwashiorkor.
  • Metabolic illness.
  • Foetal pathologies

研究组 & 干预措施

DHA supplementation

Experimental

mother consuming 400 mg/day of DHA and tehir neonates

干预措施: DHA Supplementation (Dietary Supplement)

Control (milk without DHA)

Placebo Comparator

Mothers comsuming placebo and their neonates

干预措施: Control (milk without DHA) (Dietary Supplement)

结局指标

主要结局

Change of Visual Development of newborn

时间窗: Change from Baseline at 12 months of life

Visual Evoked Potentials

次要结局

  • Change of bone turnover biomarkers in blood samples during supplementation(Change from Baseline after supplementation (2,5 months))
  • Change of oxidative stress parameters in mother milk samples during supplementation(Change from Baseline after supplementation (2,5 months))
  • Motor and cognitive development of newborn(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Julio J. Ochoa

Julio J. Ochoa, Professor, PhD

Universidad de Granada

研究点 (2)

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