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临床试验/NCT03285399
NCT03285399已完成不适用

Micronutrient Status in Breastfeeding Women and Their Children in Bhaktapur Nepal

Centre For International Health1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2008年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
1
主要终点
Prevalence of micronutrient deficiency

研究概览

简要总结

Between February 2008 and February 2009, 500 infant-mother pairs in Bhaktapur, Nepal were randomly selected in this nutritional survey. The dietary intake, nutritional status of several nutrients, growth, and breastfeeding habits were measured in both the women and their infants.The objective of this first phase was to estimate the intake and status of several nutrients in relation to breastfeeding. These mother-child pairs were revisited around the child's fifth birthday when growth, diet, and neurodevelopment was measured. The objective of this phase was to create a cohort study where factors in infancy could be related with health outcomes and development 5 years later.

详细描述

Over a period of one year, a total of 500 lactating (encompassing both exclusive and partial breastfeeding) women were enrolled in the study and completed the first 24-hour dietary recall. The women attended a hospital for physical examination, dietary interview, and blood sampling. Blood samples were also collected from their infants who also went through a detailed clinical examination

The blood samples from mothers and infant pairs were collected approximately one week apart. The blood was spun down, plasma separated and transferred into storage vials immediately. Plasma and blood pellets were stored in cryovials at -70 until analysis.

All women were also requested to provide one breast milk and one urine sample.

Plasma, blood pellet, urine, and breast milk was stored at -70 degrees celcius until analysis.

Plasma was analyzed for iron, transferrin receptor, ferritin, cobalamin, folate, vitamin A, vitamin D, vitamin E, several amino acids and other micronutrient related metabolites.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Months 至 11 Months(Child)
性别
All
接受健康志愿者

入选标准

  • availability of consent
  • no ongoing illness
  • resides in the selected cluster
  • that household information could be obtained
  • that the mother was lactating

排除标准

  • refused blood sampling
  • chronic illness

结局指标

主要结局

Prevalence of micronutrient deficiency

时间窗: 1 year

The status and prevalence of deficiencies of several micronutrients has been estimated

Predictors for micronutrient status

时间窗: 1 year

We will estimate predictors for several of the measured micronutrients using other biomarkers and clinical and demographic variables.

Prevalence of anaemia in mothers and children

时间窗: 1 year

Hemoglobin concentration is measured for all participants and the proportion anaemic and predictors for anaemia will be presented.

次要结局

  • Neurodevelopment at 5 years(5 years)
  • Growth during infancy and at 5 years of age(5 years)
  • Markers of stress and inflammation.(1 year)
  • Breastmilk b-vitamin concentration(1 year)

研究者

发起方
Centre For International Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

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