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临床试验/NCT00115271
NCT00115271已完成3 期

Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Johns Hopkins Bloomberg School of Public Health0 个研究点目标入组 5,000 人开始时间: 1999年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
5,000
主要终点
Birth weight

研究概览

简要总结

The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.

详细描述

Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination.

Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

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

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Married women of reproductive age identified as a new pregnancy using a urine test

排除标准

  • Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

结局指标

主要结局

Birth weight

3-month infant mortality

次要结局

  • Infant morbidity
  • Maternal morbidity
  • Maternal nutritional status
  • Weight gain during pregnancy
  • Infant growth

研究者

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

Parul Christian

Professor

Johns Hopkins Bloomberg School of Public Health

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