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临床试验/NCT01235767
NCT01235767已完成不适用

Effect of Animal Source Food Supplement Prior to and During Pregnancy on Birth Weight and Prematurity in Rural Vietnam

UCSF Benioff Children's Hospital Oakland1 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
291
试验地点
1
主要终点
Birth Weight

研究概览

简要总结

The purpose of this study is to determine if a nutrient-rich supplement of animal-source foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases infections, and improves birth weight and rates of prematurity compared with supplemental ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.

详细描述

It has been known for over 80 years that maternal starvation reduces fetal growth and increases neonatal infections. Many different nutrition programs have been targeted to pregnant women to improve pregnancy outcomes. The impact of these programs has been disappointing, and the prevalence of low birth weight (LBW) and infant mortality remains high, especially in developing countries. More recently, as a result of improved access to cereals following the 'green revolution,' nutritional concerns shifted from protein and energy to micronutrient deficiencies, especially those micronutrients in animal-source foods (ASFs)-iron, zinc, vitamins A and B12. Diets of pregnant women are usually limited to rice and a few vegetables, and they lack key nutrients known to reduce preterm delivery, to support fetal growth, and to prevent infections that leads to early neonatal deaths. Vietnam has a well-established farm system that supports the local production of fish, pork, poultry, and eggs. This provides an opportunity to evaluate the impact of a food-based, micronutrient-rich supplement on pregnancy outcome in high-risk, rural Vietnamese women. Since maternal nutritional status at conception is strongly linked to pregnancy outcomes, we will compare the effect of consuming a micronutrient-rich, animal-source food (ASF) supplement from pre-conception to term with a supplement from mid-gestation to term or routine prenatal care on infant birth weight, prematurity rate, and infant growth during the first 6 months of life. This study will be the first to compare a food-based, micronutrient-rich supplement consumed prior to conception to term with one given only during pregnancy. Although it is recognized by many that pregnancy may be too narrow a window to improve maternal nutritional health, it is typical for micronutrient supplements to only be given from the time of enrolling for prenatal care to term. The results of our study, therefore, will have world-wide implications regarding when maternal supplementation should be given to have the greatest impact on pregnancy outcome.

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
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-pregnant women registering to marry in the Cam Khe District of Phu Tho Province
  • Nulliparous
  • Planning to reside in the study site for the next 3 years.

排除标准

  • Have had a previous pregnancy
  • Have a history of severe infections (HIV, TB) or metabolic disease (diabetes)
  • BMI <17 kg/m2
  • Do not reside in study communes
  • Unable to provide informed consent

结局指标

主要结局

Birth Weight

时间窗: At birth

Weight of baby at birth on a scale weighing to 0.1 g made within one hour of delivery

次要结局

  • Preterm birth(At birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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