Department of Obstetrics and Gynecology, Randers Regional Hospital, Østervang 54, 8930, Randers NØ, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
BMC Pregnancy Childbirth. 2023 Mar 15;23(1):177. doi: 10.1186/s12884-023-05484-x.
The prevalence of vitamin D deficiency is high among pregnant women. Vitamin D deficiency in pregnancy is associated with increased risk of adverse pregnancy outcomes especially complications related to placental dysfunction and insulin resistance. The objective of this study is to investigate if a higher dose of vitamin D supplementation in pregnancy reduces the prevalence of vitamin D deficiency and prevents adverse pregnancy outcome with special emphasize on preeclampsia, foetal growth restriction and gestational diabetes.
GRAVITD is a double-blinded randomised trial with parallel groups where all pregnant women attending the free of charge national nuchal translucency scan programme in gestational week 10-14 at Randers Regional Hospital are invited to participate. Enrolment started in June 2020. Participants are randomised in a two armed randomization with a 1:1 allocation ratio into 1) control group - receives 10 µg of vitamin D or 2) intervention group - receives 90 µg of vitamin D. A total of 2000 pregnant women will be included. Maternal blood samples and questionnaires describing life-style habits are collected upon enrolment. For half of the participants blood samples and questionnaires will be repeated again in 3rd trimester. Blood samples will be analysed for 25-hydroxy-vitamin D using high-performance liquid chromatography coupled with tandem mass spectrometry. Upon delivery, placental tissue and umbilicalcord blood will be collected and information on maternal and fetal outcomes will be exstracted from medical records. The primary outcomes are serum levels of 25-hydroxy-vitamin D ≥ 75 nmol/L and the rate of preeclampsia, foetal growth restriction and gestational diabetes. Secondary outcome includes identification and impact on placental functions related to vitamin D. A tertiary outcome is to initiate a cohort of children born from mothers in the trial for future follow-up of the effects of vitamin D on childhood health.
Provided that this trial finds beneficial effects of a higher dose of vitamin D supplementation in pregnancies, official recommendations can be adjusted accordingly. This will provide a low-cost and easily implementable adjustment of prenatal care which can improve health for both mother and child during pregnancy and beyond.
ClinicalTrial.gov: NCT04291313 . Registered February 17, 2020.
孕妇维生素 D 缺乏症的患病率很高。妊娠期间维生素 D 缺乏与不良妊娠结局风险增加有关，特别是与胎盘功能障碍和胰岛素抵抗相关的并发症。本研究的目的是探讨妊娠期间补充较高剂量的维生素 D 是否可以降低维生素 D 缺乏症的患病率，并预防不良妊娠结局，特别是子痫前期、胎儿生长受限和妊娠期糖尿病。
GRAVITD 是一项双盲随机临床试验，采用平行组设计，邀请在妊娠 10-14 周期间在兰德斯地区医院参加免费的颈项透明层扫描计划的所有孕妇参加。招募工作于 2020 年 6 月开始。参与者按照 1:1 的比例随机分为 1) 对照组-接受 10μg 的维生素 D 或 2) 干预组-接受 90μg 的维生素 D。总共将纳入 2000 名孕妇。入组时采集母体血样并通过问卷调查描述生活方式习惯。对于一半的参与者，在妊娠 3 期时再次重复采血和问卷调查。使用高效液相色谱-串联质谱法分析 25-羟维生素 D 水平。分娩时，采集胎盘组织和脐血，并从病历中提取母婴结局信息。主要结局是血清 25-羟维生素 D 水平≥75nmol/L 和子痫前期、胎儿生长受限和妊娠期糖尿病的发生率。次要结局包括鉴定和评估与维生素 D 相关的胎盘功能。三级结局是启动一个来自试验母亲的儿童队列，以便将来随访维生素 D 对儿童健康的影响。
如果本试验发现妊娠期间补充较高剂量的维生素 D 有有益效果，那么官方建议可以相应调整。这将提供一种低成本且易于实施的产前保健调整，可以改善妊娠期间和妊娠后的母婴健康。
ClinicalTrials.gov：NCT04291313。注册于 2020 年 2 月 17 日。
