随机对照试验：口服铁剂和饮食建议与单纯饮食建议治疗非贫血缺铁的幼儿。

Randomized Trial of Oral Iron and Diet Advice versus Diet Advice Alone in Young Children with Nonanemic Iron Deficiency.

机构信息

Division of Pediatric Medicine and the Pediatric Outcomes Research Team (PORT), Hospital for Sick Children, Toronto, Ontario, Canada; Faculty of Medicine, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada; Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; Joannah & Brian Lawson Centre for Child Nutrition, Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.

Division of Pediatric Medicine and the Pediatric Outcomes Research Team (PORT), Hospital for Sick Children, Toronto, Ontario, Canada; Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.

出版信息

J Pediatr. 2021 Jun;233:233-240.e1. doi: 10.1016/j.jpeds.2021.01.073. Epub 2021 Feb 4.

DOI:10.1016/j.jpeds.2021.01.073

PMID:33548262

Abstract

OBJECTIVE

To compare the effects of 2 treatment options on neurodevelopmental and laboratory outcomes in young children with nonanemic iron deficiency.

STUDY DESIGN

A blinded, placebo-controlled, randomized trial of children 1-3 years with nonanemic iron deficiency (hemoglobin ≥110 g/L, serum ferritin <14 μg/L) was conducted in 8 primary care practices in Toronto, Canada. Interventions included ferrous sulfate or placebo for 4 months; all parents received diet advice. The primary outcome was the Early Learning Composite (ELC) using the Mullen Scales of Early Learning (mean 100, SD 15). Secondary outcomes included serum ferritin. Measurements were obtained at baseline and 4 and 12 months. Sample size was calculated to detect a between-group difference of 6-7 points in ELC.

RESULTS

At enrollment (n = 60), mean age was 24.2 (SD 7.4) months and mean serum ferritin was 10.0 (SD 2.4) μg/L. For ELC, the mean between-group difference at 4 months was 1.1 (95% CI -4.2 to 6.5) and at 12 months was 4.1 (95% CI -1.9 to 10.1). For serum ferritin, at 4 months, the mean between-group difference was 16.9 μg/L (95% CI 6.5 to 27.2), and no child randomized to ferrous sulfate had a serum ferritin <14 μg/L (0% vs 31%, P = .003).

CONCLUSIONS

For young children with nonanemic iron deficiency, treatment options include oral iron and/or diet advice. We remain uncertain about which option is superior with respect to cognitive outcomes; however, adding ferrous sulfate to diet advice resulted in superior serum ferritin outcomes after 4 months. Shared decision-making between practitioners and parents may be considered when selecting either option.

TRIAL REGISTRATION

Clinicaltrials.gov: NCT01481766.

摘要

目的

比较两种治疗方案对非贫血缺铁幼儿神经发育和实验室结果的影响。

研究设计

这是一项在加拿大多伦多 8 家初级保健机构进行的、针对 1-3 岁非贫血缺铁儿童（血红蛋白≥110g/L，血清铁蛋白＜14μg/L）的、盲法、安慰剂对照、随机试验。干预措施包括硫酸亚铁或安慰剂治疗 4 个月；所有家长均接受饮食建议。主要结局是采用 Mullen 早期学习量表（平均 100，SD 15）测量的早期学习综合评分（ELC）。次要结局包括血清铁蛋白。在基线、4 个月和 12 个月时进行测量。样本量计算以检测 ELC 组间差异 6-7 分。

结果

入组时（n=60），平均年龄为 24.2（SD 7.4）个月，平均血清铁蛋白为 10.0（SD 2.4）μg/L。在 4 个月时，ELC 组间差异的平均值为 1.1（95%CI-4.2 至 6.5），在 12 个月时为 4.1（95%CI-1.9 至 10.1）。在血清铁蛋白方面，4 个月时，组间差异的平均值为 16.9μg/L（95%CI6.5 至 27.2），且没有接受硫酸亚铁治疗的儿童的血清铁蛋白＜14μg/L（0%比 31%，P=0.003）。