Objective To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19. Design Phase 3 open label randomised controlled trial. Setting United Kingdom. Participants 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline. Interventions Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months. Main outcome measures The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat. Results Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63). Conclusions Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19. Trial registration ClinicalTrials.gov [NCT04579640][1]. Anonymised participant level data will be made available on reasonable request to a.martineau@qmul.ac.uk, subject to the terms of research ethics committee and sponsor approval. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04579640&atom=%2Fbmj%2F378%2Fbmj-2022-071230.atom

中文翻译：

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补充维生素 D 的测试与治疗方法对全因急性呼吸道感染和 covid-19 风险的影响：3 期随机对照试验 (CORONAVIT)

目的 确定在人群层面实施“测试与治疗”方法来纠正次优维生素 D 状态（25-羟基维生素 D (25(OH)D) <75 nmol/L）对全因急性呼吸道风险的影响感染和covid 19。设计第3阶段开放标签随机对照试验。设置英国。参与者 6200 名年龄≥16 岁且基线时未服用维生素 D 补充剂的人。干预措施 提供血液 25(OH)D 浓度的邮政手指点刺测试，并提供六个月的低剂量维生素 D（800 IU/天，n=1550）或高剂量维生素 D（3200 IU/天，n=1550） =1550）与那些血液 25(OH)D 浓度 <75 nmol/L 的患者相比，与未提供检测或补充的患者 (n=3100) 相比。随访为期六个月。主要结局指标 主要结局指标是至少接受过一次拭子检测或医生确认患有任何原因的急性呼吸道感染的参与者比例。次要结果是通过拭子测试确诊为 covid-19 的参与者比例。使用逻辑回归来计算优势比和相关的 95% 置信区间。主要分析是按意向治疗进行的。结果 3100 名参与者进行了维生素 D 测试，其中 2958 名 (95.4%) 接受了测试，2674 名 (86.3%) 的 25(OH)D 浓度低于 75 nmol/L，并接受了维生素 D 补充剂（n = 1328 名较低剂量，n = 1346 名较高剂量）剂量）。与无报价组的 136/2949 (4.6%) 参与者相比，低剂量组的 87/1515 (5.7%) 参与者至少发生过一次任何原因的急性呼吸道感染（优势比 1.26，95% 置信区间 0.96）较高剂量组（1.09、0.82 至 1.46）为 76/1515（5.0%）。与无报价组的 78/2949 (2.6%) 参与者相比，低剂量组 (1.39、0.98 至 1.97) 中有 55/1515 (3.6%) 的参与者感染了 covid-19，高剂量组中有 45/1515 (3.0%) 的参与者感染了 covid-19。剂量组（1.13、0.78至1.63）。结论 在维生素 D 状态不佳基线患病率较高的 16 岁及以上人群中，实施人群水平测试和治疗方法补充维生素 D 与降低全因急性呼吸道感染或2019冠状病毒病。试验注册 ClinicalTrials.gov [NCT04579640][1]。匿名参与者级别数据将根据合理请求提供给 a.martineau@qmul.ac.uk，但须遵守研究伦理委员会和申办者批准的条款。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04579640&atom=%2Fbmj%2F378%2Fbmj-2022-071230.atom