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临床试验/NCT01728766
NCT01728766已完成不适用

Longitudinal Studies of Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age, Predominantly Breast Fed, Bangladeshi Infants

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2006年7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
76
试验地点
1
主要终点
Amount of zinc transferred through breast milk

研究概览

简要总结

Data collected from this study will provide information on the breast milk zinc concentration, maternal and infant zinc status, and transfer of zinc from mothers breast milk to infants during first six months of life.

详细描述

The International Atomic Energy Agency (IAEA) has reviewed published literature to collect information for its Coordinated Research Project (CRP) on Zinc Nutrition During Early Life , and observed that there is limited information on: 1) the concentration of zinc in breast milk of mothers in lower income countries at different times post-partum; 2) the total amount of zinc transferred from mothers to infants at different ages in these settings, and 3) zinc transfer from mother to infant born with appropriate-for-gestational-age (AGA) and small-for-gestational-age (SGA). Therefore, IAEA has planned to assist local scientists to collect such information from selected countries. The International Zinc Nutrition Consultative Group (IZiNCG) has identified Bangladesh as a country with high risk of zinc deficiency (IZiNCG, 2004), where the rate of SGA infants is >30% - one of the highest in the world (de Onis, 1998). Thus, Bangladesh is an appropriate candidate country to participate in this CRP.

This study will enroll 50 healthy, full-term, newborn infants (>37 weeks gestational age by ultrasound) and their mothers if they plan to breast-feed exclusively for at least 4 months and also to continue breast feeding for at least 12 months. The infants will be examined, weighed and measured within 48 hours of birth, half of whom will be AGA (BW>2800g) and the other half SGA (BW<2500g). Infants with any acute or chronic illnesses, or congenital anomalies will not be eligible. Any mother with toxaemia, pregnancy-induced hypertension, multiple pregnancies, previously diagnosed as positive for HIV/hepatitis B infections, or habituated to smoking or alcohol consumption will also be excluded. The participants will be recruited from Nandipara, Dhaka, an urban community where the ICDDRB has ongoing clinical study facilities.

Each of the eligible mother-infant pairs will be studied in 3 separate rounds, at 4, 12 and 24 weeks post-partum. In each round, two-week studies of breast milk transfer from the mother to the infant will be carried out, using the deuterium "dose-to-the-mother" technique. In each round, the women will be requested to attend the Dhaka Hospital of ICDDR, B on day 0, for collection of baseline saliva samples from mother-infant pairs and administration of deuterium to the mothers. Study health workers will make home visits on days 1, 2, 3, 4, 13, and 14 and collect saliva samples from the infants and their mothers on days 1, 2, 13 and 14, of each round.

~2 ml of saliva will be collected for each sample from both the mother and the infant.

On days 0 and 4 of each round, 5-10 ml of manually-expressed breast milk will be collected for determining their zinc concentration. The total zinc transfer from mother to infant will be calculated as the product of the mean daily milk volume, as determined from the deuterium studies, and the mean milk zinc concentration on the days of milk collection.

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
1 Day 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • AGA, birth weight >2800 g at ≥37 weeks of gestation
  • SGA, birth weight <2500 g at ≥37 weeks of gestation

排除标准

  • Other than the above birth weight
  • Any congenital anomalies abnormalities, chronic infections as were infants with c, or acute illnesses at the time of enrollment
  • Mothers with pregnancy-induced hypertension, multiple pregnancies, known HIV or hepatitis B infection, or use of tobacco products or alcohol were excluded from the study,

结局指标

主要结局

Amount of zinc transferred through breast milk

时间窗: at 4, 12 and 24 weeks after delivery of the infants

During each round of study, a milk sample was collected during the visit to icddr,b on study day 1 and 5. On each occasion, the breast was cleansed with soap and water and rinsed with copious amounts of deionized water. The milk sample was then collected \~2-3 minutes after the feeding was initiated by momentarily removing the infant from the breast, so the study assistant could manually express 5-10 mL milk into a zinc-free beaker. The milk sample was then transferred to a plastic screw cap vial and transported to the laboratory, as described above for the saliva samples. The milk zinc concentration was measured by atomic absorption spectrometer (AAS, AA6501S, Shimadzu, Kyoto, Japan). The total zinc transfer from mother to infant was calculated as the product of the mean daily milk volume, as determined from the deuterium tracer studies, and the mean milk zinc concentration on the corresponding milk collection days.

次要结局

  • Plasma zinc content of both the mother and the infant(at 4, 12 and 24 weeks after the delivery of the infants)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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