Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D3 and/or Calcium (RECORD Trial)

Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D3 and/or Calcium (RECORD Trial)
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DOI:
10.1210/jc.2011-1309
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发表时间:
2012-02-01
影响因子:
5.8
通讯作者:
Wallace, W. Angus
Wallace, W. Angus
中科院分区:
医学2区
文献类型:
--
作者:
Avenell, Alison;MacLennan, Graeme S.;Wallace, W. Angus

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内容:维生素D或钙补充剂可能对血管疾病和癌症有影响。目的:我们的目的是调查维生素D或钙补充剂是否影响老年人的死亡率、血管疾病和癌症。设计和设置:该研究包括对来自英国21个骨科中心的2 × 2因子随机对照试验参与者的长期随访。参与者:参与者是5292人(85%的妇女),年龄至少70岁,以前的低创伤fractions.Interventions:参与者被随机分配到每日维生素D-3(800 IU),钙(1000毫克),两者,或安慰剂24-62个月,干预后3年的随访。主要结局指标:结果:在意向治疗分析中,死亡率[风险比(HR)= 0.93; 95%置信区间(CI)= 0.85 -1.02],血管疾病死亡率[HR)= 0.93; 95%置信区间(CI)= 0.85-1.02],(HR = 0.91; 95%CI = 0.79-1.05)、癌症死亡率(HR = 0.85; 95%CI = 0.68-1.06)和癌症发病率(HR = 1.07; 95%CI = 0.92-1.25)在分配维生素D的参与者和未分配维生素D的参与者之间没有显著差异。全因死亡率(HR = 1.03; 95% CI = 0.94-1.13),血管疾病死亡率(HR = 1.07; 95% CI = 0.92-1.24),癌症死亡率(HR = 1.13; 95%CI = 0.91-1.40),癌症发病率(HR = 1.06; 95%CI = 0.91-1.23)也没有显着差异之间的参与者分配钙和那些没有。在事后的统计分析调整的遵守,因此与较少的参与者,减少死亡率与维生素D和钙的死亡率增加的趋势加重,虽然所有的结果仍然nonsignificant.Conclusions:每日补充维生素D或钙并不影响死亡率,血管疾病,癌症死亡率,或癌症的发病率。(J Clin Endocrinol Metab 97:614-622,2012)
Context: Vitamin D or calcium supplementation may have effects on vascular disease and cancer.Objective: Our objective was to investigate whether vitamin D or calcium supplementation affects mortality, vascular disease, and cancer in older people.Design and Setting: The study included long-term follow-up of participants in a two by two factorial, randomized controlled trial from 21 orthopedic centers in the United Kingdom.Participants: Participants were 5292 people (85% women) aged at least 70 yr with previous low-trauma fracture.Interventions: Participants were randomly allocated to daily vitamin D-3 (800 IU), calcium (1000 mg), both, or placebo for 24-62 months, with a follow-up of 3 yr after intervention. Main Outcome Measures: All-cause mortality, vascular disease mortality, cancer mortality, and cancer incidence were evaluated.Results: In intention-to-treat analyses, mortality [hazard ratio (HR) = 0.93; 95% confidence interval (CI) = 0.85-1.02], vascular disease mortality (HR = 0.91; 95% CI = 0.79-1.05), cancer mortality (HR = 0.85; 95% CI = 0.68-1.06), and cancer incidence (HR = 1.07; 95% CI = 0.92-1.25) did not differ significantly between participants allocated vitamin D and those not. All-cause mortality (HR = 1.03; 95% CI = 0.94-1.13), vascular disease mortality (HR = 1.07; 95% CI = 0.92-1.24), cancer mortality (HR = 1.13; 95% CI = 0.91-1.40), and cancer incidence (HR = 1.06; 95% CI = 0.91-1.23) also did not differ significantly between participants allocated calcium and those not. In a post hoc statistical analysis adjusting for compliance, thus with fewer participants, trends for reduced mortality with vitamin D and increased mortality with calcium were accentuated, although all results remain nonsignificant.Conclusions: Daily vitamin D or calcium supplementation did not affect mortality, vascular disease, cancer mortality, or cancer incidence. (J Clin Endocrinol Metab 97: 614-622, 2012)