Roth Daniel E, Al Mahmud Abdullah, Raqib Rubhana, Akhtar Evana, Perumal Nandita, Pezzack Brendon, Baqui Abdullah H
Nutr J. 2013 Apr 12;12:47. doi: 10.1186/1475-2891-12-47.
Antenatal vitamin D status may be associated with the risk of adverse pregnancy and neonatal outcomes; however, the benefits of vitamin D supplementation during pregnancy remain unknown.
We conducted a double-blind placebo-controlled randomized trial to evaluate the effect of high-dose prenatal 3rd trimester vitamin D3 supplementation on maternal and neonatal (cord blood) serum 25-hydroxyvitamin D (25(OH)D) concentration (primary biochemical efficacy outcome) and maternal serum calcium concentration (primary safety measure). Eligibility criteria were pregnant women aged 18 to <35 years, at 26 to 29 weeks gestation, and residing in Dhaka, Bangladesh. 160 women were randomized by 1:1 allocation to one of two parallel intervention groups; placebo (n = 80) or 35,000 IU/week of vitamin D3 (n = 80) until delivery. All participants, study personnel and study investigators were blind to treatment allocation.
Mean maternal 25(OH)D concentration was similar in the vitamin D and placebo groups at baseline (45 vs. 44 nmol/L; p = 0.66), but was significantly higher in the vitamin D group vs. placebo group among mothers at delivery (134 vs. 38 nmol/L; p < 0.001) and newborns (cord blood: 103 vs. 39; p < 0.001). In the vitamin D group, 95% of neonates and 100% of mothers attained 25(OH)D >50 nmol/L, versus 21% mothers and 19% of neonates in the placebo group. No participants met criteria for hypercalcemia, there were no known supplement-related adverse events, and major pregnancy outcomes were similar between groups.
Antenatal 3rd-trimester vitamin D3 supplementation (35,000 IU/week) significantly raised maternal and cord serum 25(OH)D concentrations above 50 nmol/L in almost all participants without inducing hypercalcemia or other observed safety concerns. Doses up to 35,000 IU/week may be cautiously used in further research aimed at establishing the clinical effects and safety of vitamin D3 supplementation in pregnancy.
This trial was registered at ClinicalTrials.gov (NCT01126528).
产前维生素D状态可能与不良妊娠及新生儿结局风险相关；然而，孕期补充维生素D的益处仍不明确。
我们开展了一项双盲安慰剂对照随机试验，以评估孕晚期大剂量补充维生素D3对母体及新生儿（脐血）血清25-羟维生素D（25(OH)D）浓度（主要生化疗效指标）及母体血清钙浓度（主要安全性指标）的影响。纳入标准为年龄18至<35岁、孕26至29周且居住在孟加拉国达卡的孕妇。160名女性按1:1分配随机进入两个平行干预组之一；安慰剂组（n = 80）或每周35,000 IU维生素D3组（n = 80）直至分娩。所有参与者、研究人员及研究调查员均对治疗分配不知情。
维生素D组和安慰剂组基线时母体25(OH)D平均浓度相似（45对44 nmol/L；p = 0.66），但分娩时维生素D组母亲的该浓度显著高于安慰剂组（134对38 nmol/L；p < 0.001），新生儿（脐血）中也是如此（103对39；p < 0.001）。在维生素D组中，95%的新生儿和100%的母亲25(OH)D>50 nmol/L，而安慰剂组中这一比例分别为21%的母亲和19%的新生儿。无参与者符合高钙血症标准，无已知的与补充剂相关的不良事件，且两组间主要妊娠结局相似。
孕晚期补充维生素D3（每周35,000 IU）可使几乎所有参与者的母体及脐血血清25(OH)D浓度显著升高至50 nmol/L以上，且未诱发高钙血症或其他观察到的安全问题。在旨在确定孕期补充维生素D3的临床效果和安全性的进一步研究中，可谨慎使用高达每周35,000 IU的剂量。
本试验已在ClinicalTrials.gov注册（NCT01126528）。
