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双盲随机对照试验:维生素D3补充剂对老年人及其看护人急性呼吸道感染的预防作用(ViDiFlu)

2015/08/18

   摘要
   基本原理:
老年人群推荐补充低剂量维生素D以预防骨折和跌倒,但尚无临床试验研究高剂量维生素D是否能对急性呼吸道感染(ARI)产生额外的预防作用。
   目的:旨在对英国伦敦养老院街区(“片区”) 中的老年人及其看护人进行一项临床研究,运用高剂量和低剂量维生素D3用以预防ARI。
   数据和方法:54个片区(137名受试者)纳入干预组(老年人每2个月予维生素D3 2.4mg并每天予10 μg,看护人每2个月予维生素D3 3mg),54个片区(103名受试者)纳入对照组(老年人每2个月予安慰剂并每天予10 μg,看护人每2个月予安慰剂),研究持续1年。主要终点为第一次ARI发病时间;次要终点包括第一次上/下呼吸道感染发病时间(URI/LRI分别计算)及症状持续时间。
   主要结果:基线水平维生素D普遍摄入不足:240例受试者中的220例(92%)血清25(OH)D浓度低于75 nmol/L。干预组并未影响第一次ARI发病时间(校正HR(aHR) 1.18,95% CI 0.80 to 1.74, p=0.42)。分别分析URI和LRI,干预组与URI风险增加(aHR 1.48, 95% CI 1.02 to 2.16, p=0.039)、URI症状持续时间增加(干预组均数7.0天,对照组均数 5.0 天 , 几何均数矫正率 1.34, 95% CI 1.09 to 1.65, p=0.005)有关,但与 LRI风险及病程时间改变无关。
   结论:对每日低剂量服用维生素D人群,额外间歇性的单次剂量使用维生素D不能影响老年人及其看护人ARI的发生风险,但与URL的风险升高和持续时间增加有关。

 

(杨冬 审校)
Thorax. 2015 Jun 10. pii: thoraxjnl-2015-206996. doi: 10.1136/thoraxjnl-2015-206996. [Epub ahead of print]


 

 

Double-blind randomised controlled trial of vitamin D3 supplementation for the prevention of acute respiratory infection in older adults and their carers (ViDiFlu).
 

Martineau AR1, Hanifa Y2, Witt KD3, Barnes NC3, Hooper RL3, Patel M3, Stevens N3, Enayat Z3, Balayah Z3, Syed A3, Knight A4, Jolliffe DA3, Greiller CL3, McLaughlin D3, Venton TR5, Rowe M5, Timms PM5, Clark D6, Sadique Z2,Eldridge SM3, Griffiths CJ3.
 

Abstract
RATIONALE:
Low-dose vitamin D supplementation is already recommended in older adults for prevention of fractures and falls, but clinical trials investigating whether higher doses could provide additional protection against acute respiratory infection (ARI) are lacking.
OBJECTIVE:To conduct a clinical trial of high-dose versus low-dose vitamin D3 supplementation for ARI prevention in residents of sheltered-accommodation housing blocks ('schemes') and their carers in London, UK.
MEASUREMENTS AND METHODS:Fifty-four schemes (137 individual participants) were allocated to the active intervention (vitamin D3 2.4 mg once every 2 months +10 μg daily for residents, 3 mg once every 2 months for carers), and 54 schemes with 103 participants were allocated to control (placebo once every 2 months +vitamin D3 10 μg daily for residents, placebo once every 2 months for carers) for 1 year. Primary outcome was time to first ARI; secondary outcomes included time to first upper/lower respiratory infection (URI/LRI, analysed separately), and symptom duration.
MAIN RESULTS:Inadequate vitamin D status was common at baseline: 220/240 (92%) participants had serum 25(OH)D concentration <75 nmol/L. The active intervention did not influence time to first ARI (adjusted HR (aHR) 1.18, 95% CI 0.80 to 1.74, p=0.42). When URI and LRI were analysed separately, allocation to the active intervention was associated with increased risk of URI (aHR 1.48, 95% CI 1.02 to 2.16, p=0.039) and increased duration of URI symptoms (median 7.0 vs 5.0 days for active vs control, adjusted ratio of geometric means 1.34, 95% CI 1.09 to 1.65, p=0.005), but not with altered risk or duration of LRI.
CONCLUSIONS:Addition of intermittent bolus-dose vitamin D3 supplementation to a daily low-dose regimen did not influence risk of ARI in older adults and their carers, but was associated with increased risk and duration of URI.

 

Thorax. 2015 Jun 10. pii: thoraxjnl-2015-206996. doi: 10.1136/thoraxjnl-2015-206996. [Epub ahead of print]


 


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