微量营养素补充与妊娠结局：中国的双盲随机对照试验。
Micronutrient supplementation and pregnancy outcomes: double-blind randomized controlled trial in China.
机构信息
Institute of Reproductive and Child Health/Ministry of Health Key Laboratory of Reproductive Health and Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China.
出版信息
JAMA Intern Med. 2013 Feb 25;173(4):276-82. doi: 10.1001/jamainternmed.2013.1632.
BACKGROUND
Beyond perinatal folic acid supplementation, the need for additional prenatal prophylaxis of iron with or without other micronutrients remains unclear. We aim to investigate the maternal and infant health effects of iron plus folic acid and multiple micronutrient supplements vs folic acid alone when provided to pregnant women with no or mild anemia.
METHODS
In this randomized double-blind controlled trial, 18,775 nulliparous pregnant women with mild or no anemia were enrolled from 5 counties of northern China from May 2006 through April 2009. Women were randomly assigned to daily folic acid (400 μg) (control), folic acid-iron (30 mg), or folic acid, iron, and 13 additional vitamins and minerals provided before 20 weeks gestation to delivery. Primary outcome was perinatal mortality. Secondary outcomes included neonatal and infant mortality, preterm delivery, birth weight, birth length, gestational duration, and maternal hemoglobin concentration and anemia.
RESULTS
A total of 92.7% of women consumed 80% to 100% of supplements as instructed. On average, women consumed 177 supplements. Compared with daily prenatal folic acid, supplementation with iron-folic acid with or without other micronutrients did not affect the rate of perinatal mortality (8.8, 8.7, and 8.3, respectively) per 1000 births, and relative risks (RRs) were 1.00 (95% CI, 0.68-1.46; P = .99) and 0.94 (95% CI, 0.64-1.39; P = .76), respectively. Risk of other adverse maternal and infant outcomes also did not differ, except that RRs for third-trimester maternal anemia were 0.72 (95% CI, 0.63-0.83; P < .001) and 0.71 (95% CI, 0.62-0.82; P < .001), respectively.
CONCLUSION
Prenatal iron-folic acid and other micronutrient supplements provided to Chinese women with no or mild anemia prevented later pregnancy anemia beyond any benefit conferred by folic acid alone but did not affect perinatal mortality or other infant outcomes.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT00133744.
背景
除了围产期叶酸补充之外，是否需要额外进行产前铁与或不与其他微量营养素的预防仍然不清楚。我们旨在研究在无或轻度贫血的孕妇中给予铁加叶酸和多种微量营养素补充剂与单独给予叶酸相比对母婴健康的影响。
方法
在这项随机、双盲、对照试验中，2006 年 5 月至 2009 年 4 月，从中国北方的 5 个县招募了 18775 名无生育史的轻度或无贫血的孕妇。妇女被随机分配至每天接受叶酸（400μg）（对照组）、叶酸-铁（30mg）或叶酸、铁和 13 种额外的维生素和矿物质补充剂，在 20 周妊娠前至分娩时服用。主要结局是围产儿死亡率。次要结局包括新生儿和婴儿死亡率、早产、出生体重、出生身长、妊娠持续时间以及孕产妇血红蛋白浓度和贫血。
结果
92.7%的妇女平均消耗了 177 份补充剂，消耗了 80%至 100%的补充剂。与产前常规叶酸相比，补充铁-叶酸与或不补充其他微量营养素均不影响围产儿死亡率（每 1000 例活产分别为 8.8、8.7 和 8.3），相对风险（RRs）分别为 1.00（95%CI，0.68-1.46；P =.99）和 0.94（95%CI，0.64-1.39；P =.76）。其他母婴不良结局的风险也没有差异，只是第三个孕期母亲贫血的 RRs 分别为 0.72（95%CI，0.63-0.83；P<.001）和 0.71（95%CI，0.62-0.82；P<.001）。
结论
在中国无或轻度贫血的孕妇中提供产前铁-叶酸和其他微量营养素补充剂可预防叶酸单独使用以外的孕期后期贫血，但不影响围产儿死亡率或其他婴儿结局。
试验注册
clinicaltrials.gov 标识符：NCT00133744。
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