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哺乳期母亲口服维生素 D 补充剂-25(OH)D 浓度对 6 月龄纯母乳喂养婴儿的影响:一项随机、双盲、安慰剂对照试验。

Oral Vitamin D Supplementation to Mothers During Lactation-Effect of 25(OH)D Concentration on Exclusively Breastfed Infants at 6 Months of Age: A Randomized Double-Blind Placebo-Controlled Trial.

机构信息

Department of Pediatrics, University College of Medical Sciences and GTB Hospital, Delhi, India.

Department of Endocrinology, University College of Medical Sciences and GTB Hospital, Delhi, India.

出版信息

Breastfeed Med. 2020 Apr;15(4):237-245. doi: 10.1089/bfm.2019.0102. Epub 2020 Mar 16.

DOI:10.1089/bfm.2019.0102
PMID:32181677
Abstract

Exclusively breastfed infants are at risk of vitamin D deficiency. To find out proportion of exclusively breastfed infants having serum 25(OH)D concentration <11 ng/mL at 6 months of age with or without oral supplementation of vitamin D to lactating mothers. Randomized placebo-controlled study included 132 mothers and infants divided into two groups. Mothers received either vitamin D 60,000 IU between 24 and 48 hours postpartum and at 6, 10, and 14 weeks amounting to 240,000 IU of vitamin D or placebo. Serum 25(OH)D concentration in the mothers was measured at recruitment and that of infants, at birth and 6 months. Infants were evaluated for rickets at 6 months. Total 114 mother-infant dyads followed. Subjects in both groups were comparable in basic characteristics. At 6 months of age, serum 25(OH)D concentration in infants was 18.93 (5.12) ng/mL in the intervention group and 6.43 (3.76) ng/mL in the control group (mean difference = 12.5; 95% CI = 10.80-14.17;  < 0.001) and vitamin D deficiency and insufficiency was corrected in 93.1% and 38% infants, respectively, in the intervention group. There was no change in the vitamin D status of infants in the control group. In 60.3% infants (RR = 0.519; 95% CI = -0.485 to 0.735) of the intervention group 25(OH)D concentration was <20 ng/mL at 6 months of age. Six infants in the control group suffered from biochemical rickets. Radiological rickets developed in one infant in the intervention group and two infants in the control group. Serum 25(OH)D concentration of exclusively breastfed infants rise significantly when mothers are orally supplemented with 240,000 IU of vitamin D during lactation in comparison with the infants of unsupplemented mothers with 94.6% and 48.1% reduction in the risk of vitamin D deficiency and insufficiency, respectively, at 6 months of age.

摘要

纯母乳喂养的婴儿有患维生素 D 缺乏症的风险。本研究旨在观察在哺乳期给予母亲维生素 D 口服补充剂和不给母亲补充维生素 D 对 6 个月龄纯母乳喂养婴儿血清 25-羟维生素 D[25(OH)D]浓度的影响。这是一项随机安慰剂对照研究,共纳入 132 对母婴,分为两组。母亲在产后 24-48 小时内及 6、10、14 周时分别接受维生素 D60000IU(共 240000IU)或安慰剂。在招募时测量母亲的血清 25(OH)D 浓度,在婴儿出生时和 6 个月时测量婴儿的血清 25(OH)D 浓度。在 6 个月时评估婴儿的佝偻病情况。共有 114 对母婴完成了研究。两组的基本特征相似。在 6 个月龄时,干预组婴儿的血清 25(OH)D 浓度为 18.93(5.12)ng/ml,对照组为 6.43(3.76)ng/ml(平均差异=12.5;95%CI=10.80-14.17;<0.001),干预组分别有 93.1%和 38%的婴儿维生素 D 缺乏和不足得到纠正。对照组婴儿的维生素 D 状态没有变化。在干预组 60.3%(RR=0.519;95%CI=0.485-0.735)的婴儿中,6 个月龄时的血清 25(OH)D 浓度<20ng/ml。对照组有 6 例婴儿发生生化性佝偻病,干预组有 1 例婴儿出现放射学佝偻病,对照组有 2 例婴儿出现放射学佝偻病。与未接受补充维生素 D 的母亲的婴儿相比,哺乳期母亲口服补充 240000IU 维生素 D 可使纯母乳喂养婴儿的血清 25(OH)D 浓度显著升高,在 6 个月龄时,维生素 D 缺乏和不足的风险分别降低 94.6%和 48.1%。

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