Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland2The JiVitA Project, Gaibandha, Bangladesh.
JAMA. 2014;312(24):2649-58. doi: 10.1001/jama.2014.16819.
Maternal micronutrient deficiencies may adversely affect fetal and infant health, yet there is insufficient evidence of effects on these outcomes to guide antenatal micronutrient supplementation in South Asia.
To assess effects of antenatal multiple micronutrient vs iron-folic acid supplementation on 6-month infant mortality and adverse birth outcomes.
DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized, double-masked trial in Bangladesh, with pregnancy surveillance starting December 4, 2007, and recruitment on January 11, 2008. Six-month infant follow-up ended August 30, 2012. Surveillance included 127,282 women; 44,567 became pregnant and were included in the analysis and delivered 28,516 live-born infants. Median gestation at enrollment was 9 weeks (interquartile range, 7-12).
Women were provided supplements containing 15 micronutrients or iron-folic acid alone, taken daily from early pregnancy to 12 weeks postpartum.
The primary outcome was all-cause infant mortality through 6 months (180 days). Prespecified secondary outcomes in this analysis included stillbirth, preterm birth (<37 weeks), and low birth weight (<2500 g). To maintain overall significance of α = .05, a Bonferroni-corrected α = .01 was calculated to evaluate statistical significance of primary and 4 secondary risk outcomes (.05/5).
Among the 22,405 pregnancies in the multiple micronutrient group and the 22,162 pregnancies in the iron-folic acid group, there were 14,374 and 14,142 live-born infants, respectively, included in the analysis. At 6 months, multiple micronutrients did not significantly reduce infant mortality; there were 764 deaths (54.0 per 1000 live births) in the iron-folic acid group and 741 deaths (51.6 per 1000 live births) in the multiple micronutrient group (relative risk [RR], 0.95; 95% CI, 0.86-1.06). Multiple micronutrient supplementation resulted in a non-statistically significant reduction in stillbirths (43.1 vs 48.2 per 1000 births; RR, 0.89; 95% CI, 0.81-0.99; P = .02) and significant reductions in preterm births (18.6 vs 21.8 per 100 live births; RR, 0.85; 95% CI, 0.80-0.91; P < .001) and low birth weight (40.2 vs 45.7 per 100 live births; RR, 0.88; 95% CI, 0.85-0.91; P < .001).
In Bangladesh, antenatal multiple micronutrient compared with iron-folic acid supplementation did not reduce all-cause infant mortality to age 6 months but resulted in a non-statistically significant reduction in stillbirths and significant reductions in preterm births and low birth weight.
clinicaltrials.gov Identifier: NCT00860470.
母体微量营养素缺乏可能对胎儿和婴儿的健康产生不利影响，但目前还没有足够的证据表明这些结果会影响到南亚的产前微量营养素补充。
评估产前多种微量营养素与铁叶酸补充对 6 个月婴儿死亡率和不良出生结局的影响。
设计、地点和参与者：在孟加拉国进行的一项群组随机、双盲试验，妊娠监测始于 2007 年 12 月 4 日，招募于 2008 年 1 月 11 日开始。6 个月婴儿随访于 2012 年 8 月 30 日结束。监测包括 127282 名妇女；44567 名妇女怀孕并纳入分析，分娩了 28516 名活产婴儿。中位妊娠年龄为 9 周（四分位距，7-12）。
妇女每天从妊娠早期开始服用含有 15 种微量营养素或单独的铁叶酸的补充剂，直至产后 12 周。
主要结局是通过 6 个月（180 天）的全因婴儿死亡率。本分析中的预设次要结局包括死胎、早产（<37 周）和低出生体重（<2500 克）。为了保持α=0.05 的总体显著性，计算了 Bonferroni 校正的α=0.01，以评估主要和 4 项次要风险结局的统计学显著性（0.05/5）。
在多种微量营养素组的 22405 例妊娠和铁叶酸组的 22162 例妊娠中，分别有 14374 例和 14142 例活产婴儿纳入分析。在 6 个月时，多种微量营养素并没有显著降低婴儿死亡率；铁叶酸组有 764 例死亡（每 1000 例活产婴儿 54.0 例），多种微量营养素组有 741 例死亡（每 1000 例活产婴儿 51.6 例）（相对风险 [RR]，0.95；95%置信区间，0.86-1.06）。多种微量营养素补充剂导致死胎的发生率呈非统计学意义的降低（每 1000 例出生 43.1 例与 48.2 例；RR，0.89；95%置信区间，0.81-0.99；P=0.02），早产（每 100 例活产 18.6 例与 21.8 例；RR，0.85；95%置信区间，0.80-0.91；P<0.001）和低出生体重（每 100 例活产 40.2 例与 45.7 例；RR，0.88；95%置信区间，0.85-0.91；P<0.001）的发生率显著降低。
在孟加拉国，与铁叶酸补充相比，产前多种微量营养素补充并没有降低 6 个月大的婴儿的全因死亡率，但却导致死胎的发生率呈非统计学意义的降低，以及早产和低出生体重的发生率显著降低。
clinicaltrials.gov 标识符：NCT00860470。
