Vitamin D supplementation for women during pregnancy.
Vitamin D supplementation for women during pregnancy.
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DOI：
10.1590/1516-3180.20161343t2
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发表时间：
2016-05
影响因子：
8.4
通讯作者：
Pena-Rosas, Juan Pablo
中科院分区：
文献类型：
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作者：
De-Regil, Luz Maria;Palacios, Cristina;Ansary, Ali;Kulier, Regina;Pena-Rosas, Juan Pablo
维生素D缺乏或不足被认为是常见的孕妇。怀孕期间补充维生素D被认为是预防不良妊娠结局的一种干预措施。 检查是否口服补充剂维生素D单独或与钙或其他维生素和矿物质结合给予妇女在怀孕期间可以安全地改善产妇和新生儿的结果。我们检索了科克伦妊娠和分娩组的试验注册库（2015年2月23日）、国际临床试验注册平台（2015年1月31日）、论文和学位论文网络数字图书馆（2015年1月28日），并联系了相关组织（2015年1月31日）。随机和半随机试验，在个体或群体水平上进行随机化，评估妊娠期妇女单独补充维生素D或与其他微量营养素联合补充的效果。两名综述作者独立地i）根据入选标准评估研究的合格性，ii）从纳入的研究中提取数据，iii）评估纳入研究的偏倚风险。检查数据的准确性。使用GRADE方法评估证据的质量。 在这篇更新的综述中，我们纳入了15项试验，共评估了2833名女性，排除了27项试验，还有23项试验仍在进行中或未发表。9项试验比较了单独服用维生素D与不服用补充剂或安慰剂的效果，6项试验比较了维生素D和钙在不服用补充剂的情况下的效果。大多数试验的偏倚风险尚不清楚，许多研究的设盲率和脱落率偏倚风险较高。来自7项涉及868名女性的试验数据一致表明，仅接受维生素D补充剂的女性，特别是每天接受维生素D补充剂的女性，其25-羟基维生素D含量高于未接受干预或安慰剂的女性，但这种反应高度异质性。此外，来自两项涉及219名妇女的试验的数据表明，接受维生素D补充剂的妇女患先兆子痫的风险可能低于未接受干预或安慰剂的妇女（8.9% vs 15.5%;风险比（RR）0.52; 95%CI 0.25至1.05，低质量）。来自两项涉及219名妇女的试验的数据表明，服用维生素D补充剂或未干预/安慰剂的妊娠期糖尿病风险相似（RR 0.43; 95% CI 0.05，3.45，非常低质量）。在不良反应方面没有明显的差异，在一项研究中，对照组仅报告了一例肾病综合征（RR 0.17; 95%CI 0.01 - 4.06;一项试验，135名女性，低质量）。由于缺乏这一结果的数据，无法得出确切的结论。在其他任何研究中均未报告其他不良反应。关于婴儿结局，来自三项涉及477名妇女的试验的数据表明，与不干预或安慰剂相比，怀孕期间补充维生素D可降低早产风险（8.9% vs 15.5%; RR 0.36; 95% CI 0.14至0.93，中等质量）。涉及493名妇女的三项试验的数据还表明，在怀孕期间接受维生素D补充剂的妇女比那些没有接受干预或安慰剂的妇女出生体重低于2500 g的婴儿的频率更低（RR 0.40; 95% CI 0.24至0.67，中等质量）。在其他结局方面，剖腹产无明显差异（RR 0.95; 95% CI 0.69 - 1.31;两项试验; 312名妇女）;死产（RR 0.35 95% CI 0.06，1.99;三项试验，540名妇女）;或新生儿死亡（RR 0.27; 95% CI 0.04，1.67;两项试验，282名妇女）。有一些迹象表明，维生素D补充剂增加了婴儿的身长（平均差异（MD）0.70，95% CI-0.02至1.43;四项试验，638名婴儿）和出生时的头围（MD 0.43，95% CI 0.03至0.83;四项试验，638名妇女）。维生素D和钙与不补充或安慰剂相比，接受维生素D和钙的女性比未接受任何干预的女性患先兆子痫的风险更低（RR 0.51; 95% CI 0.32 - 0.80; 3项试验; 1114名妇女，中等质量），但早产风险增加（RR 1.57; 95% CI 1.02 - 2.43，3项研究，798名女性，中等质量）。在任何试验中均未报告或仅一项研究报告了足月母体维生素D浓度、妊娠期糖尿病、不良反应和低出生体重。专家结论：新的研究提供了更多的证据，证明孕妇单独补充维生素D或与钙一起补充维生素D对妊娠结局的影响。孕妇补充维生素D单次或连续剂量增加血清25-羟基维生素D在足月，并可能降低先兆子痫，低出生体重和早产的风险。然而，当维生素D和钙结合时，早产的风险增加。血清25-羟维生素D浓度升高的临床意义尚不清楚。有鉴于此，需要谨慎解释这些结果。所有研究都缺乏关于不良反应的数据。关于是否应将维生素D补充剂作为所有妇女常规产前护理的一部分以改善孕产妇和婴儿结局的证据尚不清楚。虽然有一些迹象表明，维生素D补充剂可以降低先兆子痫的风险，并增加出生时的长度和头围，但需要进一步严格的随机试验来证实这些影响。
Vitamin D deficiency or insufficiency is thought to be common among pregnant women. Vitamin D supplementation during pregnancy has been suggested as an intervention to protect against adverse pregnancy outcomes. To examine whether oral supplements with vitamin D alone or in combination with calcium or other vitamins and minerals given to women during pregnancy can safely improve maternal and neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (23 February 2015), the International Clinical Trials Registry Platform (31 January 2015), the Networked Digital Library of Theses and Dissertations (28 January 2015) and also contacted relevant organisations (31 January 2015). Randomized and quasi-randomized trials with randomization at either individual or cluster level, evaluating the effect of supplementation with vitamin D alone or in combination with other micronutrients for women during pregnancy. Two review authors independently i) assessed the eligibility of studies against the inclusion criteria ii) extracted data from included studies, and iii) assessed the risk of bias of the included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach. In this updated review we included 15 trials assessing a total of 2833 women, excluded 27 trials, and 23 trials are still ongoing or unpublished. Nine trials compared the effects of vitamin D alone versus no supplementation or a placebo and six trials compared the effects of vitamin D and calcium with no supplementation. Risk of bias in the majority of trials was unclear and many studies were at high risk of bias for blinding and attrition rates. Vitamin D alone versus no supplementation or a placebo Data from seven trials involving 868 women consistently show that women who received vitamin D supplements alone, particularly on a daily basis, had higher 25-hydroxyvitamin D than those receiving no intervention or placebo, but this response was highly heterogeneous. Also, data from two trials involving 219 women suggest that women who received vitamin D supplements may have a lower risk of pre-eclampsia than those receiving no intervention or placebo (8.9% versus 15.5%; risk ratio (RR) 0.52; 95% CI 0.25 to 1.05, low quality). Data from two trials involving 219 women suggest a similar risk of gestational diabetes among those taking vitamin D supplements or no intervention/placebo (RR 0.43; 95% CI 0.05, 3.45, very low quality). There were no clear differences in adverse effects, with only one reported case of nephritic syndrome in the control group in one study (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women, low quality). Given the scarcity of data for this outcome, no firm conclusions can be drawn. No other adverse effects were reported in any of the other studies. With respect to infant outcomes, data from three trials involving 477 women suggest that vitamin D supplementation during pregnancy reduces the risk preterm birth compared to no intervention or placebo (8.9% versus 15.5%; RR 0.36; 95% CI 0.14 to 0.93, moderate quality). Data from three trials involving 493 women also suggest that women who receive vitamin D supplements during pregnancy less frequently had a baby with a birthweight below 2500 g than those receiving no intervention or placebo (RR 0.40; 95% CI 0.24 to 0.67, moderate quality). In terms of other outcomes, there were no clear differences in caesarean section (RR 0.95; 95% CI 0.69 to 1.31; two trials; 312 women); stillbirths (RR 0.35 95% CI 0.06, 1.99; three trials, 540 women); or neonatal deaths (RR 0.27; 95% CI 0.04, 1.67; two trials, 282 women). There was some indication that vitamin D supplementation increases infant length (mean difference (MD) 0.70, 95% CI -0.02 to 1.43; four trials, 638 infants) and head circumference at birth (MD 0.43, 95% CI 0.03 to 0.83; four trials, 638 women). Vitamin D and calcium versus no supplementation or a placebo Women who received vitamin D with calcium had a lower risk of pre-eclampsia than those not receiving any intervention (RR 0.51; 95% CI 0.32 to 0.80; three trials; 1114 women, moderate quality), but also an increased risk of preterm birth (RR 1.57; 95% CI 1.02 to 2.43, three studies, 798 women, moderate quality). Maternal vitamin D concentration at term, gestational diabetes, adverse effects and low birthweight were not reported in any trial or reported only by one study. AUTHORS CONCLUSIONS: New studies have provided more evidence on the effects of supplementing pregnant women with vitamin D alone or with calcium on pregnancy outcomes. Supplementing pregnant women with vitamin D in a single or continued dose increases serum 25-hydroxyvitamin D at term and may reduce the risk of pre-eclampsia, low birthweight and preterm birth. However, when vitamin D and calcium are combined, the risk of preterm birth is increased. The clinical significance of the increased serum 25-hydroxyvitamin D concentrations is still unclear. In light of this, these results need to be interpreted with caution. Data on adverse effects were lacking in all studies. The evidence on whether vitamin D supplementation should be given as a part of routine antenatal care to all women to improve maternal and infant outcomes remains unclear. While there is some indication that vitamin D supplementation could reduce the risk of pre-eclampsia and increase length and head circumference at birth, further rigorous randomized trials are required to confirm these effects.