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母乳喂养期间每月高剂量补充母体胆钙化醇对产后5个月时母体和婴儿维生素D状态的影响:一项随机对照试验

High-Dose Monthly Maternal Cholecalciferol Supplementation during Breastfeeding Affects Maternal and Infant Vitamin D Status at 5 Months Postpartum: A Randomized Controlled Trial.

作者信息

Wheeler Benjamin J, Taylor Barry J, Herbison Peter, Haszard Jillian J, Mikhail Adel, Jones Shirley, Harper Michelle J, Houghton Lisa A

机构信息

Departments of Women's and Children's Health and Pediatric Endocrinology, Southern District Health Board, Dunedin, New Zealand

Departments of Women's and Children's Health and.

出版信息

J Nutr. 2016 Oct;146(10):1999-2006. doi: 10.3945/jn.116.236679. Epub 2016 Aug 24.

DOI:10.3945/jn.116.236679
PMID:27558577
Abstract

BACKGROUND

Many countries recommend daily infant vitamin D supplementation during breastfeeding, but compliance is often poor. A monthly, high-dose maternal regimen may offer an alternative strategy, but its efficacy is unknown.

OBJECTIVE

The objective of the study was to determine the effect of 2 different monthly maternal doses of cholecalciferol on maternal and infant 25-hydroxyvitamin D [25(OH)D] status during the first 5 mo of breastfeeding.

METHODS

With the use of a randomized, double-blind, placebo-controlled design, women who were planning to exclusively breastfeed for 6 mo (n = 90; mean age: 32.1 y; 71% exclusively breastfeeding at week 20) were randomly assigned to receive either cholecalciferol (50,000 or 100,000 IU) or a placebo monthly from week 4 to week 20 postpartum. The treatment effects relative to placebo were estimated as changes in maternal and infant serum 25(OH)D from baseline to week 20 postpartum by using a linear fixed-effects regression model. Additional secondary analyses, adjusted for potential confounders such as season of birth, vitamin D-fortified formula intake, and infant or maternal skin color, were also conducted.

RESULTS

After 16 wk of supplementation, changes in maternal serum 25(OH)D were significantly higher in the 50,000-IU/mo (12.8 nmol/L; 95% CI: 0.4, 25.2 nmol/L) and 100,000-IU/mo (21.5 nmol/L; 95% CI: 9.2, 33.8 nmol/L) groups than in the placebo group (P = 0.43 and P < 0.001, respectively). For infants, the unadjusted mean changes in serum 25(OH)D were 4.5 nmol/L (95% CI: -16.2, 25.0 nmol/L) for the 50,000-IU/mo group and 15.8 nmol/L (95% CI: -4.7, 36.4 nmol/L) for the 100,000-IU/mo group, but the changes did not differ from the placebo reference group. However, after adjustment for season of birth, vitamin D-fortified formula intake, and infant skin color, the mean change effect size for the 100,000-IU/mo group was 19.1 nmol/L (95% CI: 2.5, 35.6 nmol/L; P = 0.025) higher than that in the placebo group.

CONCLUSIONS

Maternal cholecalciferol supplementation at a dose of 100,000 IU/mo during the first 5 mo of breastfeeding potentially benefits infant vitamin D status. Further studies are required to determine optimum dose and dosing frequency. This trial was registered at www.anzctr.org.au as ACTRN12611000108910.

摘要

背景

许多国家建议在母乳喂养期间每日给婴儿补充维生素D,但依从性往往较差。每月一次的高剂量母亲用药方案可能提供一种替代策略,但其疗效尚不清楚。

目的

本研究的目的是确定两种不同的每月母亲剂量胆钙化醇对母乳喂养前5个月母婴25-羟基维生素D[25(OH)D]状态的影响。

方法

采用随机、双盲、安慰剂对照设计,计划纯母乳喂养6个月的妇女(n = 90;平均年龄:32.1岁;20周时71%为纯母乳喂养)在产后第4周到第20周被随机分配,每月接受胆钙化醇(50,000或100,000 IU)或安慰剂。通过线性固定效应回归模型,估计相对于安慰剂的治疗效果为产后第20周母婴血清25(OH)D相对于基线的变化。还进行了额外的二次分析,对潜在混杂因素如出生季节、维生素D强化配方奶摄入量以及婴儿或母亲肤色进行了校正。

结果

补充16周后,50,000 IU/月组(12.8 nmol/L;95% CI:0.4,25.2 nmol/L)和100,000 IU/月组(21.5 nmol/L;95% CI:9.2,33.8 nmol/L)母亲血清25(OH)D的变化显著高于安慰剂组(分别为P = 0.43和P < 0.001)。对于婴儿,50,000 IU/月组血清25(OH)D的未校正平均变化为4.5 nmol/L(95% CI:-16.2,25.0 nmol/L),100,000 IU/月组为15.8 nmol/L(95% CI:-4.7,36.4 nmol/L),但这些变化与安慰剂参照组无差异。然而,在对出生季节、维生素D强化配方奶摄入量和婴儿肤色进行校正后,100,000 IU/月组的平均变化效应量比安慰剂组高19.1 nmol/L(95% CI:2.5,35.6 nmol/L;P = 0.025)。

结论

母乳喂养前5个月母亲每月补充100,000 IU胆钙化醇可能有益于婴儿维生素D状态。需要进一步研究以确定最佳剂量和给药频率。本试验在www.anzctr.org.au注册,注册号为ACTRN12611000108910。

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