De-Regil Luz Maria, Palacios Cristina, Ansary Ali, Kulier Regina, Peña-Rosas Juan Pablo
Evidence and Programme Guidance, Department of Nutrition for Health and Development, World Health Organization, Geneva,Switzerland.
Cochrane Database Syst Rev. 2012 Feb 15;2(2):CD008873. doi: 10.1002/14651858.CD008873.pub2.
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 gestational outcomes.
To examine whether 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 (31 October 2011), the International Clinical Trials Registry Platform (ICTRP) (31 October 2011), the Networked Digital Library of Theses and Dissertations (28 October 2011) and also contacted relevant organisations (8 April 2011).
Randomised and quasi-randomised trials with randomisation 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 search strategy identified 34 potentially eligible references. We included six trials assessing a total of 1023 women, excluded eight studies, and 10 studies are still ongoing. Five trials involving 623 women compared the effects of vitamin D alone versus no supplementation/placebo and one trial with 400 women compared the effects of vitamin D and calcium versus no supplementation.Only one trial with 400 women reported on pre-eclampsia: women who received 1200 IU vitamin D along with 375 mg of elemental calcium per day were as likely to develop pre-eclampsia as women who received no supplementation (average risk ratio (RR) 0.67; 95% confidence interval (CI) 0.33 to 1.35). Data from four trials involving 414 women consistently show that women who received vitamin D supplements had higher concentrations of vitamin D in serum at term than those women who received no intervention or a placebo; however the magnitude of the response was highly heterogenous. Data from three trials involving 463 women suggest that women who receive vitamin D supplements during pregnancy less frequently had a baby with a birthweight below 2500 grams than those women receiving no treatment or placebo; statistical significance was borderline (RR 0.48; 95% CI 0.23 to 1.01).In terms of other conditions, there were no significant differences in adverse side effects including nephritic syndrome (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women); stillbirths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) or neonatal deaths (RR 0.17; 95% CI 0.01 to 4.06; one trial, 135 women) between women who received vitamin D supplements in comparison with women who received no treatment or placebo. No studies reported on preterm birth, maternal death, admission to neonatal intensive care unit/special nursery or Apgar scores.
AUTHORS' CONCLUSIONS: Vitamin D supplementation in a single or continued dose during pregnancy increases serum vitamin D concentrations as measured by 25-hydroxyvitamin D at term. The clinical significance of this finding and the potential use of this intervention as a part of routine antenatal care are yet to be determined as the number of high quality trials and outcomes reported is too limited to draw conclusions on its usefulness and safety. Further rigorous randomised trials are required to evaluate the role of vitamin D supplementation in pregnancy.
维生素D缺乏或不足在孕妇中被认为很常见。孕期补充维生素D被建议作为一种预防不良妊娠结局的干预措施。
研究孕期单独补充维生素D或与钙或其他维生素及矿物质联合补充,是否能安全改善母婴结局。
我们检索了Cochrane妊娠与分娩组试验注册库(2011年10月31日)、国际临床试验注册平台(ICTRP)(2011年10月31日)、学位论文网络数字图书馆(2011年10月28日),并于2011年4月8日联系了相关组织。
个体或整群水平随机化的随机和半随机试验,评估孕期单独补充维生素D或与其他微量营养素联合补充的效果。
两位综述作者独立进行:i)根据纳入标准评估研究的合格性;ii)从纳入研究中提取数据;iii)评估纳入研究的偏倚风险。检查数据的准确性。
检索策略识别出34篇潜在合格参考文献。我们纳入了6项试验,共评估1023名女性,排除8项研究,10项研究仍在进行中。5项涉及623名女性的试验比较了单独补充维生素D与不补充/安慰剂的效果,1项涉及400名女性的试验比较了维生素D和钙与不补充的效果。只有1项涉及400名女性的试验报告了子痫前期情况:每天接受1200IU维生素D加375mg元素钙的女性发生子痫前期的可能性与未接受补充的女性相同(平均风险比(RR)0.67;95%置信区间(CI)0.33至1.35)。4项涉及414名女性的试验数据一致显示,接受维生素D补充剂的女性足月时血清维生素D浓度高于未接受干预或安慰剂的女性;然而,反应程度高度异质性。3项涉及463名女性的试验数据表明,孕期接受维生素D补充剂的女性生出出生体重低于2500克婴儿的频率低于未接受治疗或安慰剂的女性;统计学意义接近临界值(RR 0.48;95%CI 0.23至1.01)。在其他情况方面,补充维生素D的女性与未接受治疗或安慰剂的女性相比,在包括肾病综合征(RR 0.17;95%CI 0.01至4.06;1项试验,135名女性)、死产(RR 0.17;95%CI 0.01至4.06;1项试验,135名女性)或新生儿死亡(RR 0.17;95%CI 0.01至4.06;1项试验,135名女性)等不良副作用方面没有显著差异。没有研究报告早产、孕产妇死亡、入住新生儿重症监护病房/特殊保育室或阿氏评分情况。
孕期单次或持续补充维生素D可使足月时通过25-羟维生素D测量的血清维生素D浓度升高。由于高质量试验数量和报告的结局有限,无法就其有效性和安全性得出结论,因此这一发现的临床意义以及将该干预措施作为常规产前护理一部分的潜在用途尚待确定。需要进一步严格的随机试验来评估孕期补充维生素D的作用。