Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women A Randomized Clinical Trial
Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women A Randomized Clinical Trial
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DOI：
10.1001/jama.2017.2115
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发表时间：
2017-03-28
影响因子：
120.7
通讯作者：
McDonnell, Sharon L.
中科院分区：
文献类型：
--
作者：
Lappe, Joan;Watson, Patrice;McDonnell, Sharon L.
重要性证据表明，维生素D水平低可能会增加患癌症的风险。目的：确定膳食补充维生素D-3和钙是否能降低老年妇女患癌症的风险。设计、环境和参与者：在31个农村县进行的一项为期4年、双盲、安慰剂对照、基于人群的随机临床试验（2009年6月24日至2015年8月26日-随访结束日期）。共有2303名55岁或以上的健康绝经后妇女被随机分组，1156名到治疗组，1147名到安慰剂组。治疗时间为4年。干预措施治疗组（维生素d -3 +钙组）给予维生素d -3 2000 IU/d、钙1500mg/d；安慰剂组接受相同的安慰剂。主要结局和测量主要结局是所有类型癌症（不包括非黑色素瘤皮肤癌）的发生率，使用Kaplan-Meier生存分析和比例风险模型进行评估。结果在2303名随机女性中（平均年龄65.2岁[SD， 7.0]；平均基线血清25-羟基维生素D水平为32.8 ng/mL [SD, 10.5]）， 2064名（90%）完成了研究。在第一年，维生素D-3 +钙组血清25-羟基维生素D水平为43.9 ng/mL，安慰剂组为31.6 ng/mL。109名参与者被确诊为癌症，维生素D-3 +钙组45名（3.89%），安慰剂组64名（5.58%）（差异为1.69% [95% CI, -0.06%至3.46%];P = 0.06）。维生素D-3 +钙组4年Kaplan-Meier发病率为0.042 (95% CI, 0.032 ~ 0.056)，安慰剂组为0.060 (95% CI, 0.048 ~ 0.076)；P = 0。06。在未调整的Cox比例风险回归中，风险比为0.70 （95% CI, 0.47 ~ 1.02）。与研究相关的潜在不良事件包括肾结石（维生素D-3 +钙组16名参与者，安慰剂组10名参与者）和血清钙水平升高（维生素D-3 +钙组6名，安慰剂组2名）。在平均基线血清25-羟基维生素D水平为32.8 ng/mL的健康绝经后老年妇女中，与安慰剂相比，补充维生素D-3和钙并没有导致4年全类型癌症的风险显著降低。需要进一步的研究来评估维生素D在预防癌症方面的可能作用。
IMPORTANCE Evidence suggests that low vitamin D status may increase the risk of cancer.OBJECTIVE To determine if dietary supplementation with vitamin D-3 and calcium reduces the risk of cancer among older women.DESIGN, SETTING, AND PARTICIPANTS A 4-year, double-blind, placebo-controlled, population-based randomized clinical trial in 31 rural counties (June 24, 2009, to August 26, 2015-the final date of follow-up). A total of 2303 healthy postmenopausal women 55 years or older were randomized, 1156 to the treatment group and 1147 to the placebo group. Duration of treatment was 4 years.INTERVENTIONS The treatment group (vitamin D-3 + calcium group) received 2000 IU/d of vitamin D-3 and 1500mg/d of calcium; the placebo group received identical placebos.MAIN OUTCOMES AND MEASURES The primary outcomewas the incidence of all-type cancer (excluding nonmelanoma skin cancers), which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling.RESULTS Among 2303 randomized women (mean age, 65.2 years [SD, 7.0]; mean baseline serum 25-hydroxyvitamin D level, 32.8 ng/mL [SD, 10.5]), 2064 (90%) completed the study. At year 1, serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D-3 + calcium group and 31.6 ng/mL in the placebo group. A new diagnosis of cancer was confirmed in 109 participants, 45 (3.89%) in the vitamin D-3 + calcium group and 64 (5.58%) in the placebo group (difference, 1.69% [95% CI, -0.06% to 3.46%]; P =.06). Kaplan-Meier incidence over 4 years was 0.042 (95% CI, 0.032 to 0.056) in the vitamin D-3 + calcium group and 0.060 (95% CI, 0.048 to 0.076) in the placebo group; P =.06. In unadjusted Cox proportional hazards regression, the hazard ratio was 0.70 (95% CI, 0.47 to 1.02). Adverse events potentially related to the study included renal calculi (16 participants in the vitamin D-3 + calcium group and 10 in the placebo group), and elevated serum calcium levels (6 in the vitamin D-3 + calcium group and 2 in the placebo group).CONCLUSIONS AND RELEVANCE Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL, supplementation with vitamin D-3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years. Further research is necessary to assess the possible role of vitamin D in cancer prevention.