Effect of Different Dosages of Oral Vitamin D Supplementation on Vitamin D Status in Healthy, Breastfed Infants A Randomized Trial
Effect of Different Dosages of Oral Vitamin D Supplementation on Vitamin D Status in Healthy, Breastfed Infants A Randomized Trial
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DOI：
10.1001/jama.2013.3404
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发表时间：
2013-05-01
影响因子：
120.7
通讯作者：
Weiler, Hope
中科院分区：
文献类型：
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作者：
Gallo, Sina;Comeau, Kathryn;Weiler, Hope
重要性维生素D补充在婴儿期是必要的，以支持健康的骨矿物质增长。每天补充400 IU维生素D被认为可以支持血浆25-羟基维生素D（25[OH]D）浓度在40和50 nmol/L之间;有些人主张75 - 150 nmol/L的维生素D对骨骼健康有益。目的研究不同剂量的维生素D在支持婴儿25（OH）D浓度方面的功效。设计，设置，在2007年3月至2010年8月期间，在加拿大魁北克蒙特利尔的132名一个月大的健康足月母乳喂养婴儿中进行了双盲随机临床试验。婴儿随访11个月，截至2011年8月（74%完成研究）。干预参与者被随机分配接受口服胆钙化醇（维生素D-3）补充剂400 IU/d（n=39），800 IU/d（n=39），1200 IU/d（n=38），或1600 IU/d（n=16）。主要结果和测量主要结果是97.5%的婴儿在3个月时血浆25（OH）D浓度为75 nmol/L或更高。次要结局包括97.5%的婴儿在6、9和12个月时25（OH）D浓度≥ 75 nmol/L;所有时间25（OH）D浓度≥ 50 nmol/L;生长;全身和局部骨矿物质含量。数据采用意向治疗法、逻辑回归和混合模型方差分析进行分析。400-IU/d组婴儿的25（OH）D浓度达到75 nmol/L或更高（95% CI，38%-72%），800-IU/d组为92%（95% CI，65%-91%），1200-IU/d组为92%（95% CI，77%-98%），1600-IU/d组为100%。在任何一组中，97.5%的婴儿在12个月时都没有维持这种浓度。由于血浆25（OH）D浓度升高，提前停用1600 IU/d剂量。所有剂量均在97%（95% CI，94%-100%）的3个月婴儿中建立了25（OH）D浓度50 nmol/L或更高，并在98%（95% CI，94%-100%）至12个月内维持该浓度。生长和骨矿物质含量并没有不同dosage.Conclusions和相关性在健康，长期，母乳喂养的婴儿，只有维生素D补充剂量为1600 IU/d（但不是剂量400，800，或1200 IU/d）增加血浆25（OH）D浓度为75 nmol/L或更高的婴儿在3个月的97.5%。然而，这种剂量增加25（OH）D浓度的水平，已与高钙血症。
Importance Vitamin D supplementation in infancy is required to support healthy bone mineral accretion. A supplement of 400 IU of vitamin D per day is thought to support plasma 25-hydroxyvitamin D (25[OH]D) concentrations between 40 and 50 nmol/L; some advocate 75 to 150 nmol/L for bone health.Objective To investigate the efficacy of different dosages of vitamin D in supporting 25(OH)D concentrations in infants.Design, Setting, and Participants Double-blind randomized clinical trial conducted among 132 one-month-old healthy, term, breastfed infants from Montreal, Quebec, Canada, between March 2007 and August 2010. Infants were followed up for 11 months ending August 2011 (74% completed study).Intervention Participants were randomly assigned to receive oral cholecalciferol (vitamin D-3) supplements of 400 IU/d (n=39), 800 IU/d (n=39), 1200 IU/d (n=38), or 1600 IU/d (n=16).Main Outcomes and Measures The primary outcome was a plasma 25(OH)D concentration of 75 nmol/L or greater in 97.5% of infants at 3 months. Secondary outcomes included 25(OH)D concentrations of 75 nmol/L or greater in 97.5% of infants at 6, 9, and 12 months; 25(OH)D concentrations of 50 nmol/L or greater across all times; growth; and whole body and regional bone mineral content. Data were analyzed by intention to treat using available data, logistic regression, and mixed-model analysis of variance.Results By 3 months, 55% (95% CI, 38%-72%) of infants in the 400-IU/d group achieved a 25(OH)D concentration of 75 nmol/L or greater vs 81%(95% CI, 65%-91%) in the 800-IU/d group, 92% (95% CI, 77%-98%) in the 1200-IU/d group, and 100% in the 1600-IU/d group. This concentration was not sustained in 97.5% of infants at 12 months in any of the groups. The 1600-IU/d dosage was discontinued prematurely because of elevated plasma 25(OH)D concentrations. All dosages established 25(OH)D concentrations of 50 nmol/L or greater in 97% (95% CI, 94%-100%) of infants at 3 months and sustained this in 98% (95% CI, 94%-100%) to 12 months. Growth and bone mineral content did not differ by dosage.Conclusions and Relevance Among healthy, term, breastfed infants, only a vitamin D supplement dosage of 1600 IU/d (but not dosages of 400, 800, or 1200 IU/d) increased plasma 25(OH)D concentration to 75 nmol/L or greater in 97.5% of infants at 3 months. However, this dosage increased 25(OH)D concentrations to levels that have been associated with hypercalcemia.