Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness.
Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness.
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DOI：
10.1002/jbmr.463
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发表时间：
2011-10
影响因子：
6.2
通讯作者：
Wagner, Carol L.
中科院分区：
文献类型：
--
作者：
Hollis, Bruce W.;Johnson, Donna;Hulsey, Thomas C.;Ebeling, Myla;Wagner, Carol L.
怀孕期间补充维生素D的必要性，安全性和有效性仍然存在争议。在这项随机对照试验中，妊娠12-16周的单胎妊娠妇女每天接受400、2000或4000 IU维生素D3，直至分娩。主要结局是分娩时母体/新生儿循环25（OH）D，次要结局是达到25（OH）D ≥80 nmol/L和达到最大1，25（OH）2D产生所需的25（OH）D浓度。在494名入组的妇女中，350名妇女持续到分娩：分娩时和分娩前1个月的平均25（OH）D组间差异显著（p<0.0001），达到充足的百分比组间差异显著，4000 IU组最大（p<0.0001）。分娩后1个月内达到≥80 nmol/L的相对风险（RR）在2000 IU与400 IU之间存在显著差异（RR 1.52 [CI 1.24-1.86]）; 4000 IU与400 IU之间存在显著差异（RR 1.60 [CI 1.32-1.95]），但4000 IU与2000 IU之间无显著差异（RR 1.06 [CI 0.93-1.19]）。在整个妊娠期间，循环25（OH）D对循环1，25（OH）2D浓度有直接影响（p<0.0001），在4000 IU组的所有分层中，1，25（OH）2D的产生最大。两组之间的任何安全性指标均无差异。没有一个不良事件归因于维生素D补充或循环25（OH）D水平。孕妇补充维生素D 4,000 IU/天是安全的，在所有妇女及其新生儿中实现充足性是最有效的，而目前估计的平均需求量在实现充足的循环25（OH）D方面相对无效，特别是在非洲裔美国人中。
The need, safety and effectiveness of vitamin D supplementation during pregnancy remain controversial. In this randomized controlled trial, women with a singleton pregnancy at 12–16 weeks’ gestation received 400, 2000 or 4000 IU vitamin D3/day until delivery. The primary outcome was maternal/neonatal circulating 25(OH)D at delivery, with secondary outcomes 25(OH)D ≥80 nmol/L achieved and 25(OH)D concentration required to achieve maximal 1,25(OH)2D production. Of the 494 women enrolled, 350 women continued until delivery: Mean 25(OH)D by group at delivery and 1-month before delivery were significantly different (p<0.0001), and percent who achieved sufficiency was significantly different by group, greatest in 4000 IU group (p<0.0001). The relative risk (RR) for achieving ≥80 nmol/L within one month of delivery was significantly different between 2000 vs. 400 IU (RR 1.52 [CI 1.24–1.86]); 4000 vs. 400 (RR 1.60 [CI 1.32–1.95]), but not between 4000 vs. 2000 (RR 1.06 [CI 0.93–1.19]). Circulating 25(OH)D had a direct influence on circulating 1,25(OH)2D concentrations throughout pregnancy (p<0.0001) with maximal production of 1,25(OH)2D in all strata in the 4000 IU group. There were no differences between groups on any safety measure. Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels. Vitamin D supplementation of 4,000 IU/day for pregnant women was safe and most effective in achieving sufficiency in all women and their neonates regardless of race while the current estimated average requirement was comparatively ineffective at achieving adequate circulating 25(OH)D, especially in African Americans.
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