Kołodziejczyk Alicja, Borszewska-Kornacka Maria K, Seliga-Siwecka Joanna
Neonatal and Intensive Care Department, Medical University of Warsaw, Karowa 2 Street, 00-315, Warsaw, Poland.
Trials. 2017 Sep 11;18(1):424. doi: 10.1186/s13063-017-2141-y.
The pivotal role of vitamin D (vit D) in skeletal health is well known. Neonatal vit D storage at birth is dependent on maternal levels, and newborns receive 50-70% of their mother's 25-hydroxyvitamin D [25(OH)D]. Deficiency of vit D can lead to prematurity bone disease, with an incidence of up to 55% in infants weighing < 1000 g. The aim of this study is to assess the effectiveness of monitored supplementation of vit D in a population of preterm infants.
METHODS/DESIGN: Preterm infants born at 24-32 weeks of gestation will be recruited within the first 7 days of life. Depending on the type of feeding, and after reaching partial enteral feeding or at 7 days of life, vit D supplementation will consist of 500 IU and an additional 150-300 IU/kg included in human milk fortifiers (if fed exclusively with breast milk) or 190 IU/kg in milk formulas. Subjects will be randomised to either monitored (with an option of dose modification based on 25(OH)D levels as per protocol) or standard therapy up to 52 weeks of post-conceptional age (PCA). The primary outcome measure will be the number of neonates with deficiency or excess levels of 25(OH)D at 40 ±2 weeks of PCA. Additional 25(OH)D levels will be measured at birth, at 4 and 8 weeks of age, and/or at 35 and 52 ±2 weeks of PCA. Secondary objectives will include the incidence of osteopenia, nephrocalcinosis and nephrolithiasis. Serum parameters of calcium phosphorus metabolism will also be measured.
Despite multiple years of research and numerous publications, there is still a lack of consensus in regard to how much vit D infants should receive and how long they should receive it. Because 80% of calcium and phosphorus placental transfer occurs between 24 and 40 weeks of gestation, preterm infants are especially prone to adverse effects of vit D insufficiency. However, both inadequate and excessive amounts of vit D may be unsafe and lead to serious health issues. The results of our study may shed new light on these concerns and contribute to optimising vit D supplementation.
ClinicalTrials.gov, NCT03087149 . Registered on 15 March 2017.
维生素D（vit D）在骨骼健康中的关键作用众所周知。新生儿出生时的vit D储备取决于母体水平，新生儿从母亲那里获得其25-羟基维生素D[25(OH)D]的50-70%。vit D缺乏可导致早产骨病，体重<1000 g的婴儿发病率高达55%。本研究的目的是评估监测补充vit D对早产儿群体的有效性。
方法/设计：孕周为24-32周的早产儿将在出生后的前7天内招募。根据喂养方式，在达到部分肠内喂养后或出生后7天，vit D补充量将为500 IU，对于纯母乳喂养的婴儿，母乳强化剂中还将额外添加150-300 IU/kg（如果仅以母乳喂养），或配方奶中添加190 IU/kg。受试者将被随机分为监测组（根据方案，可根据25(OH)D水平选择调整剂量）或标准治疗组，直至孕龄（PCA）52周。主要结局指标将是在PCA 40±2周时25(OH)D水平缺乏或过量的新生儿数量。在出生时、4周和8周龄时，和/或在PCA 35周和52±2周时测量额外的25(OH)D水平。次要目标将包括骨质减少、肾钙质沉着症和肾结石的发病率。还将测量钙磷代谢的血清参数。
尽管经过多年研究和大量出版物，但关于婴儿应接受多少vit D以及应接受多长时间仍缺乏共识。由于80%的钙和磷通过胎盘转移发生在妊娠24至40周之间，早产儿尤其容易受到vit D不足的不利影响。然而，vit D不足和过量都可能不安全，并导致严重的健康问题。我们研究的结果可能会为这些问题提供新的线索，并有助于优化vit D补充。
ClinicalTrials.gov，NCT03087149。于2017年3月15日注册。
