Urinary tract stone occurrence in the Women's Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements
Urinary tract stone occurrence in the Women's Health Initiative (WHI) randomized clinical trial of calcium and vitamin D supplements
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DOI：
10.3945/ajcn.110.003350
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发表时间：
2011-07-01
影响因子：
7.1
通讯作者：
Masaki, Kamal
中科院分区：
文献类型：
--
作者：
Wallace, Robert B.;Wactawski-Wende, Jean;Masaki, Kamal
背景资料：妇女健康倡议（WHI）钙加维生素D（CaD）补充剂的随机临床试验（RCT）发现，补充组的尿路结石发病率高出17%。本研究评估了这种风险是否受参与者特征的影响。目的：我们研究了WHI试验中CaD组尿路结石发生的相关性。设计：我们分析了一项随机对照试验，涉及来自40个WHI中心的36，282名年龄在50-79岁的绝经后妇女：18，176名妇女接受500 mg碳酸钙加200 IU维生素D（3），每日两次（分别为1000 mg和400 IU），18，106名妇女接受匹配的安慰剂，平均7.0年。尿路结石的发病率determined.Results：自我报告的临床诊断的尿路结石的发病率是更常见的活性CaD药物治疗组比安慰剂组（危害比：1.17; 95%CI：1.02，1.34）：449名妇女在CaD组和381名妇女在安慰剂组在试验期间报告了结石。根据随机分配，各种人口统计学、拟人化、饮食和其他假设的风险因素之间的自报结石率没有差异。无论是总钙摄入量还是基线时钙补充剂的使用都与结石的风险无关。在敏感性分析，审查参与者低于80%的依从性，结果是similar.Conclusions：每日补充钙7 y与自我报告的尿路结石的数量增加。这些发现对CaD补充剂的使用有影响。本试验在WHI注册，网址为clinicaltrials.gov，注册号为NCT 00000611。美国临床营养杂志2011;94：270-7.
Background: The Women's Health Initiative (WHI) randomized clinical trial (RCT) of calcium plus vitamin D (CaD) supplements found a 17% excess in urinary tract stone incidence in the supplemented group. This study evaluated whether this risk is modified by participant characteristics.Objective: We examined the correlates of urinary tract stone occurrence in the CaD arm of the WHI trial.Design: We analyzed an RCT involving 36,282 postmenopausal women aged 50-79 y from 40 WHI centers: 18,176 women received 500 mg calcium carbonate plus 200 IU vitamin D(3) twice daily (1000 mg and 400 IU daily, respectively), and 18,106 women received a matching placebo for an average of 7.0 y. The incidence of urinary tract stones was determined.Results: The incidence of self-reported clinically diagnosed urinary tract stones was more common in the active CaD medication group than in the placebo group (hazard ratio: 1.17; 95% CI: 1.02, 1.34): 449 women in the CaD group and 381 women in the placebo group reported a stone during the trial. The rates of self-reported stones did not differ between various demographic, anthropomorphic, dietary, and other hypothesized risk factors according to randomization assignment. Neither the total calcium intake nor the use of calcium supplements at baseline was associated with the risk of stones. In sensitivity analyses that censored participants who were below 80% adherence, the findings were similar.Conclusions: Daily supplementation with CaD for 7 y was associated with an increase in the number of self-reported urinary tract stones. These findings have implications for CaD supplement use. This trial was registered with the WHI at clinicaltrials.gov as NCT00000611. Am J Clin Nutr 2011;94:270-7.