Department of Neonatology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, 342005, India.
Department of Biochemistry, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Eur J Pediatr. 2022 Sep;181(9):3473-3482. doi: 10.1007/s00431-022-04533-5. Epub 2022 Jun 21.
This open-label, block-randomized controlled trial compared the effect of 800 IU/day and 400 IU/day of oral vitamin D supplementation in reducing vitamin D insufficiency (VDI) among healthy-term breastfed infants at 14 weeks of postnatal age. All eligible infants were randomized to receive either 800 or 400 IU/day of oral vitamin D (starting within the first week until 14 weeks). The primary outcome was the proportion of infants with VDI (25-OH-D < 20 ng/ml) at 14 weeks. Secondary outcomes were vitamin D deficiency (VDD, < 12 ng/ml), severe VDD (< 5 ng/ml), anthropometry, biochemical or clinical rickets, and any adverse events related to vitamin D toxicity (VDT). Among 102 enrolled infants, the distribution of baseline variables (including cord 25-OH-D levels; 13.0 versus 14.2 ng/ml) was similar in both groups. On intention-to-treat analysis, the proportions of infants with VDI at 14 weeks were significantly lower in the 800 IU group compared to those in the 400 IU group [24% versus 55%; RR 0.44; 95% CI: 0.25-0.76]. The proportions of infants with elevated parathormone (6% versus 26.5%; p = 0.012) and severe VDD (0% versus 12.2%; p = 0.033) were significantly lower in the 800 IU group. Clinical rickets developed in three (6.2%) infants in the 400 IU group. No infant developed VDT. Conclusions: Daily oral supplementation with 800 IU of vitamin D resulted in an almost 50% reduction in the proportion of infants with VDI and prevented the occurrence of severe VDD at 14 weeks of age compared to 400 IU with no evidence of vitamin D toxicity. Trial Registration: Clinical Trial Registry of India (CTRI/2019/02/017374). What is Known: • Breastfeeding is the ideal source of nutrition for healthy-term breastfed infants; however, vitamin D content of breastmilk is suboptimal. • AAP recommends daily oral supplementation of 400 IU of vitamin D to all healthy-term breastfed infants; however, trials from high-income countries support insufficiency of this dose in maintaining serum 25-OH-D levels >20 ng/ml with no such information from low-middle-income countries. What is New: • 800 IU/day of oral vitamin D3 supplementation among term breastfed infants significantly reduces vitamin D insufficiency at 14 weeks' age as compared to the recommended dose of 400 IU/day. • This higher supplemental dose is safe with no evidence of vitamin D toxicity.
这项开放标签、分组随机对照试验比较了 800IU/天和 400IU/天口服维生素 D 补充剂对 14 周龄健康足月母乳喂养婴儿维生素 D 不足（VDI）的影响。所有符合条件的婴儿均被随机分配接受 800IU/天或 400IU/天的口服维生素 D（从出生后第一周开始至 14 周）。主要结局是 14 周时 VDI（25-OH-D<20ng/ml）婴儿的比例。次要结局是维生素 D 缺乏症（VDD，<12ng/ml）、严重 VDD（<5ng/ml）、人体测量、生化或临床佝偻病以及与维生素 D 毒性（VDT）相关的任何不良事件。在 102 名入组婴儿中，两组的基线变量（包括脐带 25-OH-D 水平；13.0 与 14.2ng/ml）分布相似。在意向治疗分析中，800IU 组在 14 周时 VDI 婴儿的比例明显低于 400IU 组[24%比 55%；RR 0.44；95%CI：0.25-0.76]。800IU 组甲状旁腺激素升高（6%比 26.5%；p=0.012）和严重 VDD（0%比 12.2%；p=0.033）的婴儿比例明显更低。400IU 组有 3 名（6.2%）婴儿出现临床佝偻病。没有婴儿发生 VDT。结论：与 400IU 相比，每日口服补充 800IU 维生素 D 可使 VDI 婴儿的比例降低近 50%，并可预防 14 周龄时严重 VDD 的发生，且无维生素 D 毒性的证据。试验注册：印度临床试验注册中心（CTRI/2019/02/017374）。已知：•母乳喂养是健康足月母乳喂养婴儿的理想营养来源；然而，母乳中的维生素 D 含量并不理想。•AAP 建议所有健康足月母乳喂养的婴儿每天口服补充 400IU 维生素 D；然而，来自高收入国家的试验支持该剂量不足以维持血清 25-OH-D 水平>20ng/ml，而来自中低收入国家的试验则没有此类信息。新内容：•与推荐剂量 400IU/天相比，每日口服补充 800IU 维生素 D3 可显著降低 14 周龄足月母乳喂养婴儿的维生素 D 不足。•这种更高的补充剂量是安全的，没有维生素 D 毒性的证据。
