Center for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N Wolfe St, Baltimore, MD 21205, USA.
JAMA. 2011 May 18;305(19):1986-95. doi: 10.1001/jama.2011.656.
Maternal vitamin A deficiency is a public health concern in the developing world. Its prevention may improve maternal and infant survival.
To assess efficacy of maternal vitamin A or beta carotene supplementation in reducing pregnancy-related and infant mortality.
DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized, double-masked, placebo-controlled trial among pregnant women 13 to 45 years of age and their live-born infants to 12 weeks (84 days) postpartum in rural northern Bangladesh between 2001 and 2007. Interventions Five hundred ninety-six community clusters (study sectors) were randomized for pregnant women to receive weekly, from the first trimester through 12 weeks postpartum, 7000 μg of retinol equivalents as retinyl palmitate, 42 mg of all-trans beta carotene, or placebo. Married women (n = 125,257) underwent 5-week surveillance for pregnancy, ascertained by a history of amenorrhea and confirmed by urine test. Blood samples were obtained from participants in 32 sectors (5%) for biochemical studies.
All-cause mortality of women related to pregnancy, stillbirth, and infant mortality to 12 weeks (84 days) following pregnancy outcome.
Groups were comparable across risk factors. For the mortality outcomes, neither of the supplement group outcomes was significantly different from the placebo group outcomes. The numbers of deaths and all-cause, pregnancy-related mortality rates (per 100,000 pregnancies) were 41 and 206 (95% confidence interval [CI], 140-273) in the placebo group, 47 and 237 (95% CI, 166-309) in the vitamin A group, and 50 and 250 (95% CI, 177-323) in the beta carotene group. Relative risks for mortality in the vitamin A and beta carotene groups were 1.15 (95% CI, 0.75-1.76) and 1.21 (95% CI, 0.81-1.81), respectively. In the placebo, vitamin A, and beta carotene groups the rates of stillbirth and infant mortality were 47.9 (95% CI, 44.3-51.5), 45.6 (95% CI, 42.1-49.2), and 51.8 (95% CI, 48.0-55.6) per 1000 births and 68.1 (95% CI, 63.7-72.5), 65.0 (95% CI, 60.7-69.4), and 69.8 (95% CI, 65.4-72.3) per 1000 live births, respectively. Vitamin A compared with either placebo or beta carotene supplementation increased plasma retinol concentrations by end of study (1.46 [95% CI, 1.42-1.50] μmol/L vs 1.13 [95% CI, 1.09-1.17] μmol/L and 1.18 [95% CI, 1.14-1.22] μmol/L, respectively; P < .001) and reduced, but did not eliminate, gestational night blindness (7.1% for vitamin A vs 9.2% for placebo and 8.9% for beta carotene [P < .001 for both]).
Use of weekly vitamin A or beta carotene in pregnant women in Bangladesh, compared with placebo, did not reduce all-cause maternal, fetal, or infant mortality.
clinicaltrials.gov Identifier: NCT00198822.
发展中国家的孕产妇维生素 A 缺乏是一个公共卫生问题。预防这种情况可能会改善母婴的生存。
评估在孟加拉国农村地区，孕妇补充维生素 A 或β-胡萝卜素对减少妊娠相关和婴儿死亡的效果。
设计、地点和参与者：在孟加拉国农村地区，2001 年至 2007 年间，对 13 至 45 岁的孕妇及其活产婴儿进行了为期 12 周（84 天）的产后随访。采用群组随机、双盲、安慰剂对照试验。596 个社区组（研究组）随机分配孕妇每周接受 7000μg 视黄醇当量（以棕榈酸视黄酯形式）、42mg 全反式β-胡萝卜素或安慰剂，从妊娠早期到产后 12 周。已婚妇女（n=125257）接受了 5 周的妊娠监测，通过闭经史和尿妊娠试验确认妊娠。从 32 个（5%）组的参与者中抽取血样进行生化研究。
与妊娠、死产和婴儿死亡相关的孕产妇全因死亡率。
各组在危险因素方面具有可比性。对于死亡率结果，与安慰剂组相比，补充组的任何一个结局都没有显著差异。死亡人数和全因、妊娠相关死亡率（每 10 万例妊娠）分别为安慰剂组 41 例和 206 例（95%置信区间[CI]，140-273）、维生素 A 组 47 例和 237 例（95%CI，166-309）和β-胡萝卜素组 50 例和 250 例（95%CI，177-323）。维生素 A 和β-胡萝卜素组的死亡率相对风险分别为 1.15（95%CI，0.75-1.76）和 1.21（95%CI，0.81-1.81）。在安慰剂、维生素 A 和β-胡萝卜素组中，死产和婴儿死亡率分别为 47.9%（95%CI，44.3-51.5）、45.6%（95%CI，42.1-49.2）和 51.8%（95%CI，48.0-55.6）每 1000 例活产，和 68.1%（95%CI，63.7-72.5）、65.0%（95%CI，60.7-69.4）和 69.8%（95%CI，65.4-72.3）每 1000 例活产。与安慰剂或β-胡萝卜素补充剂相比，维生素 A 补充剂使研究结束时的血浆视黄醇浓度增加（1.46[95%CI，1.42-1.50]μmol/L比 1.13[95%CI，1.09-1.17]μmol/L和 1.18[95%CI，1.14-1.22]μmol/L，P<.001），并减少了，但没有消除妊娠期夜盲症（维生素 A 组为 7.1%，安慰剂组为 9.2%，β-胡萝卜素组为 8.9%，P<.001）。
与安慰剂相比，孟加拉国孕妇每周补充维生素 A 或β-胡萝卜素并不能降低母婴或婴儿的全因死亡率。
临床试验.gov 标识符：NCT00198822。
