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老年人补充维生素D与骨折发生率。一项随机、安慰剂对照临床试验。

Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo-controlled clinical trial.

作者信息

Lips P, Graafmans W C, Ooms M E, Bezemer P D, Bouter L M

机构信息

Vrije Universiteit, Amsterdam, The Netherlands.

出版信息

Ann Intern Med. 1996 Feb 15;124(4):400-6. doi: 10.7326/0003-4819-124-4-199602150-00003.

DOI:10.7326/0003-4819-124-4-199602150-00003
PMID:8554248
Abstract

OBJECTIVE

To determine whether vitamin D supplementation decreases the incidence of hip fractures and other peripheral bone fractures.

DESIGN

Prospective, double-blind trial.

SETTING

Community setting (Amsterdam and surrounding area).

PATIENTS

2578 persons (1916 women, 662 men) 70 years of age and older (mean age +/- SD, 80 +/- 6 years) living independently, in apartments for elderly persons, or in homes for elderly persons.

INTERVENTION

Participants were randomly assigned to receive either vitamin D3, 400 IU in one tablet daily, or placebo for a maximum of 3.5 years.

MEASUREMENTS

Dietary calcium intake and serum 25-hydroxyvitamin D [25(OH)D] were estimated in a subset of participants. During follow-up, attention was concentrated on hip fractures and other peripheral fractures. The maximal follow-up period was 4 years. The results were evaluated by survival analysis.

RESULTS

Mean dietary calcium intake from dairy products was 868 mg/d. Mean serum 25(OH)D concentration in the third year of the study was 23 nmol/L in the placebo group and 60 nmol/L in the vitamin D group. Median follow-up was 3.5 years, and total follow-up was 8450 patient-years. During follow-up, 306 persons in the placebo group and 282 persons in the vitamin D group died (P = 0.20). Hip fractures occurred in 48 persons in the placebo group and 58 persons in the vitamin D group (P = 0.39, intention-to-treat analysis). Other peripheral fractures occurred in 74 persons in the placebo group and 77 persons in the vitamin D group (P = 0.86).

CONCLUSION

Our results do not show a decrease in the incidence of hip fractures and other peripheral fractures in Dutch elderly persons after vitamin D supplementation.

摘要

目的

确定补充维生素D是否会降低髋部骨折及其他外周骨骨折的发生率。

设计

前瞻性双盲试验。

地点

社区环境(阿姆斯特丹及周边地区)。

患者

2578名年龄在70岁及以上(平均年龄±标准差,80±6岁)的独立生活、居住在老年公寓或养老院的人(1916名女性,662名男性)。

干预措施

参与者被随机分配,每天服用一片含400国际单位维生素D3的药物或安慰剂,最长持续3.5年。

测量指标

在部分参与者中估算膳食钙摄入量和血清25-羟维生素D [25(OH)D]水平。随访期间,重点关注髋部骨折和其他外周骨折。最大随访期为4年。通过生存分析评估结果。

结果

乳制品的平均膳食钙摄入量为868毫克/天。在研究的第三年,安慰剂组的平均血清25(OH)D浓度为23纳摩尔/升,维生素D组为60纳摩尔/升。中位随访时间为3.5年,总随访时间为8450患者年。随访期间,安慰剂组有306人死亡,维生素D组有282人死亡(P = 0.20)。安慰剂组有48人发生髋部骨折,维生素D组有58人发生髋部骨折(P = 0.39,意向性分析)。安慰剂组有74人发生其他外周骨折,维生素D组有77人发生其他外周骨折(P = 0.86)。

结论

我们的研究结果未显示补充维生素D后荷兰老年人髋部骨折及其他外周骨折的发生率有所降低。

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