Creighton University Schools of Nursing, Omaha, Nebraska.
University of California San Diego, Department of Family Medicine and Public Health, La Jolla, California.
JAMA. 2017 Mar 28;317(12):1234-1243. doi: 10.1001/jama.2017.2115.
IMPORTANCE: Evidence suggests that low vitamin D status may increase the risk of cancer. OBJECTIVE: To determine if dietary supplementation with vitamin D3 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 D3 + calcium group) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium; the placebo group received identical placebos. MAIN OUTCOMES AND MEASURES: The primary outcome was 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 D3 + 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 D3 + 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 D3 + 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 D3 + calcium group and 10 in the placebo group), and elevated serum calcium levels (6 in the vitamin D3 + 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 D3 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01052051.
重要性：有证据表明，维生素 D 状态低下可能会增加癌症风险。
目的：确定维生素 D3 和钙的膳食补充剂是否可以降低老年女性的癌症风险。
设计、地点和参与者：这是一项为期 4 年的、双盲、安慰剂对照、基于人群的随机临床试验，在 31 个农村县进行（2009 年 6 月 24 日至 2015 年 8 月 26 日-最后随访日期）。共有 2303 名健康的绝经后 55 岁及以上的女性被随机分配，1156 名进入治疗组，1147 名进入安慰剂组。治疗时间为 4 年。
干预措施：治疗组（维生素 D3+钙组）每天服用 2000 IU 的维生素 D3 和 1500 mg 的钙；安慰剂组服用相同的安慰剂。
主要结果和测量指标：主要结局是所有类型癌症（不包括非黑素瘤皮肤癌）的发病率，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[标准差 7.0]；平均基线血清 25-羟维生素 D 水平 32.8ng/ml[标准差 10.5]），2064 名（90%）完成了研究。在第 1 年，维生素 D3+钙组的血清 25-羟维生素 D 水平为 43.9ng/ml，安慰剂组为 31.6ng/ml。109 名参与者被确诊为癌症，其中 45 名（3.89%）在维生素 D3+钙组，64 名（5.58%）在安慰剂组（差异 1.69%[95%CI，-0.06% 至 3.46%]；P=0.06）。4 年内 Kaplan-Meier 发病率在维生素 D3+钙组为 0.042（95%CI，0.032 至 0.056），在安慰剂组为 0.060（95%CI，0.048 至 0.076）；P=0.06。未调整的 Cox 比例风险回归显示，风险比为 0.70（95%CI，0.47 至 1.02）。与研究相关的潜在不良事件包括肾结石（维生素 D3+钙组 16 例，安慰剂组 10 例）和血清钙水平升高（维生素 D3+钙组 6 例，安慰剂组 2 例）。
结论和相关性：在平均基线血清 25-羟维生素 D 水平为 32.8ng/ml 的健康绝经后老年女性中，与安慰剂相比，维生素 D3 和钙的补充并不能在 4 年内显著降低所有类型癌症的风险。需要进一步研究来评估维生素 D 在癌症预防中的可能作用。
试验注册：clinicaltrials.gov 标识符：NCT01052051。
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