Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
研究概览
地位
详细说明
The project focuses on brain-behavior effects depending on the timing of iron deficiency (ID) and iron repletion in human infants. Iron deficiency (ID) is the world's most common single nutrient disorder, differentially affecting pregnant women and infants everywhere. The study promises to be the first systematic investigation of brain and behavior effects of prenatal dietary iron deficiency in human infants. The design will support comparisons of brain/behavior effects depending on the timing and duration of ID. The study will assess reversibility of effects, depending on timing of ID and its treatment, and examine maternal vs. fetal iron regulatory mechanisms in placenta and white blood cells. State-of-the-art neurophysiologic and behavioral measures will test specific hypotheses regarding effects of ID on sensory, motor, cognitive, affective-social and regulatory functions related to impaired myelination of sensory/motor systems and altered structure, neurotransmitter function and neurometabolism in targeted brain regions (basal ganglia and hippocampus). The study will be conducted in China, a rapidly developing country where ID often occurs among pregnant women and infants in the absence of generalized undernutrition. Cord blood hemoglobin (Hb) and ferritin concentrations will be measured in 1300 rural full-term infants, with iron status determined again at 9 and 18 mo. Brain-behavior assessments in the perinatal period will involve 359 infants ("newborn cohort"): 59 with low Hb ("low birth iron" group) will receive iron; 200 with marginal Hb or low cord ferritin ("marginal birth iron" group) will be randomly assigned at 6 wk, 50 to iron therapy and 150 to vitamins only; and 100 with normal cord Hb and ferritin levels ("normal birth iron" group) will receive vitamins only. The remaining 763 infants with cord blood testing will form the "blood screen cohort." At 9 and 18 mo, the newborn cohort will be reassessed, along with IDA infants from the blood screen cohort - about 58 at 9 mo ("early postnatal IDA") and 48 at 18 mo ("late postnatal IDA"). Approximately 39 marginal-birth-iron vitamins only-treated infants in the newborn cohort may also have IDA at 9 mo ("combined ID"). IDA infants will be treated with vitamins with iron. Differential effects and/or reversibility depending on timing of ID or treatment could inform health policy and practice worldwide. However, the effects of prenatal iron deficiency have received very little study in human infants due in large part to previous thinking, no longer accepted, that the infant was protected. Up to 75% of pregnant women worldwide are anemic, with about half due to ID. An estimated 20-25% of 6- to 24-mo-old infants have IDA, and more have ID without anemia. Thus, the public health implications of study findings could be profound.
The project is expected to continue with a 5-year follow-up (Aug 2013-July 2017).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310003
- Children's Hospital, Zhejiang University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- infants born at Maternity and Children's Hospitals of Fuyang city in China
- healthy term newborns from uncomplicated pregnancies for hematology screening
- healthy full-term singleton infants with cord Hb and ferritin in the low-marginal or normal range for developmental testing
Exclusion Criteria:
- perinatal complications
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Low birth iron
Infants with low birth iron who receive vitamins A and D + iron
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a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.)
and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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实验性的:Marginal birth iron 1
Infants with marginal birth iron randomized to receive vitamins A and D + iron
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a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.)
and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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有源比较器:Marginal birth iron 2
Infants with marginal birth iron randomized to receive vitamins A and D without iron
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a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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有源比较器:Normal birth iron
Infants with normal birth iron who receive vitamins A and D without iron
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a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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实验性的:Combined ID
Marginal-birth-iron vitamins only-treated infants who have IDA at 9 mo.
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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实验性的:Early postnatal IDA
Infants with IDA at 9 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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实验性的:Late postnatal IDA
Infants with IDA at 18 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks.
These infants were also not anemic when screened at 9 months.
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Infant behavior and development
大体时间:6 weeks; 9 and 18 months
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6 weeks; 9 and 18 months
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次要结果测量
结果测量 |
大体时间 |
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Infant anemia
大体时间:9 and 18 months
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9 and 18 months
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Low or marginal birth iron
大体时间:6 weeks
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6 weeks
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合作者和调查者
调查人员
- 首席研究员:Betsy Lozoff, MD、University of Michigan
- 研究主任:Jie Shao, MD、Children's Hospital, Zhejiang University School of Medicine
- 研究主任:Zhengyan Zhao, MD、Children's Hospital, Zhejiang University School of Medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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