Schümann K, Longfils P, Monchy D, von Xylander S, Weinheimer H, Solomons N W
Central Institute for Nutrition and Dietary Research, Technical University Munich, Germany.
Eur J Clin Nutr. 2009 Mar;63(3):355-68. doi: 10.1038/sj.ejcn.1602930. Epub 2007 Oct 31.
To determine the differential efficacy and safety of twice-weekly administration of 3 RDAs of iron and folic acid, with and without a complement of 2 RDAs of 11, and 1 RDA of 3 additional essential micronutrients as compared to a placebo control (PlbCON) given as foodLETs.
SUBJECTS/METHODS: A total of 250 children aged 6-24 months were enrolled after recruitment by village health workers; 19 of them dropped out during the trial. Children were assigned to one of three treatment arms and followed for 20.5 weeks; 41 supervised twice-weekly dosings of 30 mg of iron plus folic acid, either with or without accompanying micronutrients or placebo were given as foodLETs, a tool for ready-to-eat fortification in infant food. Initial and final measurements of anthropometry and blood biomarkers for hematological, iron stores and inflammatory status, as well as for abnormal hemoglobin (Hb), were obtained. Symptoms of listlessness, vomiting, watery stools and acute respiratory infections were monitored weekly.
Iron-containing supplements increased Hb concentrations significantly (P<0.0001) and virtually eradicated any IDA, as compared to no change in hematological status in the PlbCON group (P=0.011). Iron stores, as reflected by ferritin, increased significantly with iron-containing treatments (P<0.0001). Responses were as effective in individuals with HbE as in those with exclusively HbA phenotypes. Watery stools (P=0.002) and listlessness (P=0.001) were significantly more frequent in those receiving iron and folic acid alone than in the PlbCON group. In contrast, acute respiratory infections (P=0.014) and listlessness (P=0.001) were significantly less frequent in those receiving the multiple micronutrient formulation than in the PlbCON group.
Supplementation of micronutrients along with iron and folic acid mitigates the excess morbidity of iron-folate alone, without reducing its efficacy in correcting anemia and building iron stores. FoodLETs are a suitable vehicle to provide micronutrient supplementation to infants.
确定每周两次服用3个推荐膳食摄入量（RDA）的铁和叶酸，同时补充或不补充2个RDA的维生素A、1个RDA的其他3种必需微量营养素，与作为食物强化剂（FoodLETs）给予的安慰剂对照（PlbCON）相比的差异疗效和安全性。
受试者/方法：通过乡村卫生工作者招募了总共250名6 - 24个月大的儿童；其中19名在试验期间退出。儿童被分配到三个治疗组之一，并随访20.5周；41名儿童接受每周两次、每次30毫克铁加叶酸的给药，无论是否伴有微量营养素或安慰剂，均作为食物强化剂给予，这是一种用于婴儿食品即食强化的工具。获得了人体测量以及血液中血液学、铁储备和炎症状态生物标志物以及异常血红蛋白（Hb）的初始和最终测量值。每周监测无精打采、呕吐、水样便和急性呼吸道感染的症状。
与PlbCON组血液学状态无变化（P = 0.011）相比，含铁补充剂显著提高了Hb浓度（P < 0.0001），并几乎消除了所有缺铁性贫血（IDA）。以铁蛋白反映的铁储备在含铁治疗中显著增加（P < 0.0001）。HbE个体的反应与仅具有HbA表型的个体一样有效。仅接受铁和叶酸的儿童水样便（P = 0.002）和无精打采（P = 0.001）的发生率显著高于PlbCON组。相比之下，接受多种微量营养素配方的儿童急性呼吸道感染（P = 0.）和无精打采（P = 0.001）的发生率显著低于PlbCON组。
微量营养素与铁和叶酸一起补充可减轻单独补充铁 - 叶酸时的额外发病率，同时不降低其纠正贫血和建立铁储备的功效。食物强化剂是为婴儿提供微量营养素补充的合适载体。
