A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants

A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants
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DOI:
10.1067/s0022-3476(03)00301-9
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发表时间:
2003-11-01
影响因子:
5.1
通讯作者:
Adams, RJ
Adams, RJ
中科院分区:
医学2区
文献类型:
--
作者:
Friel, JK;Aziz, K;Adams, RJ

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目的:检测补铁是否会影响足月母乳喂养婴儿的血液学、生化和发育状况。研究设计:77名足月母乳喂养的婴儿(n = 77)被随机选择,从1到6个月大,每天接受7.5毫克硫酸亚铁元素铁或安慰剂。调查人员和家属不知道小组分配。在1个月、3.5个月、6个月和12个月时分析全血细胞计数和铁蛋白、红细胞超氧化物歧化酶、过氧化氢酶、血浆铁还原抗氧化能力以及锌和铜水平。从12个月到18个月,评估Bayley精神和精神运动发育指数(MDI和PDI)和视力(使用Teller视力卡)。通过方差分析和t检验进行的分析是有意治疗。结果:补充铁导致6月龄时血红蛋白和平均红细胞体积升高,13月龄时视力和PDI显著提高(100 +/- 12 vs 93 +/- 9 [+/- SD])。治疗组和安慰剂组在人体测量指标、依从性、生化状态或人口统计学特征方面没有差异。结论:母乳喂养的婴儿补充铁似乎是安全的,并且可能对一些婴儿的血液和发育有有益的影响。
Objectives: To test whether iron supplementation affects hematologic, biochemical, and developmental status in term breast-fed infants.Study design: Term breast-fed infants (n = 77) were randomly selected to receive either 7.5 mg per day of elemental iron as ferrous sulfate or placebo from I to 6 months of age. Investigators and families were unaware of group assignment. Complete blood count and ferritin, red cell superoxide dismutase, catalase, plasma ferric reducing antioxidant power, and zinc and copper levels were analyzed at 1, 3.5, 6, and 12 months of age. Bayley mental and psychomotor developmental indexes (MDI and PDI) and visual acuity (with the use of Teller acuity cards) were assessed from 12 to IS months of age. Analysis performed by analysis of variance and t tests was by intention to treat.Results: Iron supplementation resulted in higher hemoglobin and mean corpuscular volume at 6 months of age and significantly higher visual acuity and PDI at 13 months of age (100 +/- 12 vs 93 +/- 9 [+/- SD]). Treatment and placebo groups did not differ in anthropometric indexes, compliance, biochemical status, or demographic characteristics.Conclusions: Iron supplementation of breast-fed infants appears safe and might have beneficial hematologic and developmental effects for some infants.