School of Human Nutrition, McGill University, Sainte-Anne-de-Bellevue, Quebec, Canada.
Department of Biochemistry, Memorial University of Newfoundland, St John's, Newfoundland and Labrador, Canada.
JAMA Pediatr. 2023 Apr 1;177(4):353-362. doi: 10.1001/jamapediatrics.2022.5837.
The dose of supplemental vitamin D needed in infants born with serum 25-hydroxyvitamin D (25[OH]D) concentrations less than 50 nmol/L (ie, 20 ng/mL) is unclear.
To determine whether a higher dose (1000 IU vs 400 IU per day) is required in infants born with 25(OH)D concentrations less than 50 nmol/L for bone mineral accretion across infancy.
DESIGN, SETTING, AND PARTICIPANTS: In this prespecified secondary analysis of a double-blinded randomized clinical trial, conducted from March 2016 to March 2019 in a single center in Greater Montreal, Quebec, Canada, a consecutive sample of 139 healthy term singletons were recruited from 866 infants screened for vitamin D status at birth. Data were analyzed from June 2021 to November 2022.
Capillary blood was collected 24 to 36 hours after birth to measure serum total 25(OH)D concentrations. Infants with 25(OH)D concentrations less than 50 nmol/L were randomized to receive either 1000 IU or 400 IU per day of oral vitamin D3 supplementation from age 1 to 12 months. Infants with 25(OH)D concentrations of 50 nmol/L or greater formed a reference group.
Measures at age 1, 3, 6, and 12 months were preplanned and included whole-body bone mineral content, lumbar spine bone mineral content, and bone mineral density using dual-energy x-ray absorptiometry, and serum 25(OH)D3 using liquid chromatography tandem mass spectrometry.
Of 139 included infants, 81 (58.3%) were male, and the median (IQR) gestational age at birth was 39.6 (38.9-40.6) weeks. A total of 49 infants were included in the 1000 IU per day group, 49 infants in the 400 IU per day group, and 41 in the reference group. Mean (SD) whole-body bone mineral content was not different between trial groups over time (1000 IU per day, 173.09 [2.36] g; 400 IU per day, 165.94 [66.08] g). Similarly, no differences were observed in lumbar spine bone mineral content or density. Mean (SD) serum 25(OH)D3 concentrations were significantly higher in the 1000 IU per day group from age 3 to 12 months (3 months, 115.2 [35.3] nmol/L; 6 months, 121.6 [34.4] nmol/L; 12 months, 99.6 [28.8] nmol/L) compared with the 400 IU per day trial group (3 months, 77.4 [23.3] nmol/L; 6 months, 85.1 [18.6] nmol/L; 12 months, 82.3 [14.3] nmol/L).
In this study, a higher dose of vitamin D supplementation in infants born with 25(OH)D concentrations less than 50 nmol/L did not present advantages to bone mass in infancy. This study supports a standard dose of 400 IU per day of vitamin D supplementation for breastfed infants in Montreal.
ClinicalTrials.gov Identifier: NCT02563015.
对于血清 25-羟维生素 D（25（OH）D）浓度低于 50nmol/L（即 20ng/mL）出生的婴儿，需要多少补充维生素 D 剂量尚不清楚。
确定在 25（OH）D 浓度低于 50nmol/L 的婴儿中，每天补充 1000IU 与 400IU 相比，是否更有利于婴儿期的骨矿物质积累。
设计、地点和参与者：这是一项在加拿大魁北克省大蒙特利尔的一个单一中心进行的双盲随机临床试验的预设二次分析，从 2016 年 3 月至 2019 年 3 月进行，连续招募了 866 名出生时筛查维生素 D 状态的健康足月单胎婴儿中的 139 名。数据分析于 2021 年 6 月至 2022 年 11 月进行。
在出生后 24 至 36 小时采集毛细血管血，以测量血清总 25（OH）D 浓度。25（OH）D 浓度低于 50nmol/L 的婴儿随机分为每天接受 1000IU 或 400IU 口服维生素 D3 补充剂，从 1 至 12 个月龄。25（OH）D 浓度为 50nmol/L 或更高的婴儿为参考组。
1、3、6 和 12 个月时的测量是预先计划的，包括全身骨矿物质含量、腰椎骨矿物质含量和使用双能 X 射线吸收法的骨矿物质密度，以及使用液相色谱串联质谱法测量血清 25（OH）D3。
在纳入的 139 名婴儿中，81 名（58.3%）为男性，出生时的中位（IQR）胎龄为 39.6（38.9-40.6）周。共有 49 名婴儿被纳入每天 1000IU 组，49 名婴儿被纳入每天 400IU 组，41 名婴儿被纳入参考组。随着时间的推移，试验组之间的全身骨矿物质含量平均值（SD）没有差异（每天 1000IU，173.09[2.36]g；每天 400IU，165.94[66.08]g）。同样，腰椎骨矿物质含量或密度也没有差异。与每天 400IU 组相比，每天 1000IU 组从 3 至 12 个月龄的血清 25（OH）D3 浓度显著更高（3 个月，115.2[35.3]nmol/L；6 个月，121.6[34.4]nmol/L；12 个月，99.6[28.8]nmol/L）（3 个月，77.4[23.3]nmol/L；6 个月，85.1[18.6]nmol/L；12 个月，82.3[14.3]nmol/L）。
在这项研究中，对于 25（OH）D 浓度低于 50nmol/L 的婴儿，较高剂量的维生素 D 补充并不能在婴儿期带来骨量优势。本研究支持在蒙特利尔为母乳喂养的婴儿提供每天 400IU 维生素 D 补充的标准剂量。
ClinicalTrials.gov 标识符：NCT02563015。
