膳食硝酸盐补充剂预防和减轻养老院冬季感染（包括 COVID-19）严重程度的效果（BEET-Winter）：一项随机安慰剂对照可行性试验。
Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter): a randomised placebo-controlled feasibility trial.
机构信息
Stroke Trials Unit, Mental Health and Clinical Neuroscience, School of Medicine, University of Nottingham, South Block D Floor, Nottingham, NG7 2UH, UK.
Stroke, Nottingham University Hospitals NHS Trust, Nottingham, NG7 2UH, Nottinghamshire, UK.
出版信息
Eur Geriatr Med. 2022 Dec;13(6):1343-1355. doi: 10.1007/s41999-022-00714-5. Epub 2022 Nov 16.
PURPOSE
Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in care home residents.
METHODS
We performed a cluster-randomised placebo-controlled trial in UK residential and nursing care home residents and compared nitrate containing (400 mg) versus free (0 mg daily) beetroot juice given for 60 days. Outcomes comprised feasibility of recruitment, adherence, salivary and urinary nitrate, and ordinal infection/clinical events.
RESULTS
Of 30 targeted care homes in late 2020, 16 expressed interest and only 6 participated. 49 residents were recruited (median 8 [interquartile range 7-12] per home), mean (standard deviation) age 82 (8) years, with proxy consent 41 (84%), advance directive for hospital non-admission 8 (16%) and ≥ 1 doses of COVID-19 vaccine 37 (82%). Background dietary nitrate was < 30% of acceptable daily intake. 34 (76%) residents received > 50% of juice. Residents randomised to nitrate vs placebo had higher urinary nitrate levels, median 50 [18-175] v 18 [10-50] mg/L, difference 25 [0-90]. Data paucity precluded clinical between-group comparisons; the outcome distribution was as follows: no infection 32 (67%), uncomplicated infection 0, infection requiring healthcare support 11 (23%), all-cause hospitalisation 5 (10%), all-cause mortality 0. Urinary tract infections were most common.
CONCLUSIONS
Recruiting UK care homes during the COVID-19 pandemic was partially successful. Supplemented dietary nitrate was tolerated and elevated urinary nitrate. Together, infections, hospitalisations and deaths occurred in 33% of residents over 60 days. A larger trial is now required.
TRIAL REGISTRATION
ISRCTN51124684. Application date 7/12/2020; assignment date 13/1/2021.
目的
感染会导致养老院患者大量发病和死亡。一氧化氮（NO）在体外具有广谱抗病毒、抗细菌和抗酵母活性。我们评估了在养老院居民中补充膳食硝酸盐（NO 底物）摄入的可行性。
方法
我们在英国的养老院居民中进行了一项集群随机安慰剂对照试验，比较了含有硝酸盐（400mg）和不含硝酸盐（每天 0mg）的甜菜根汁，干预时间为 60 天。结果包括招募的可行性、依从性、唾液和尿液中的硝酸盐以及等级感染/临床事件。
结果
2020 年底，对 30 家目标养老院进行了调查，其中 16 家表示有兴趣，只有 6 家参与。共招募了 49 名居民（中位数 8 [四分位间距 7-12] 名/家），平均（标准差）年龄 82（8）岁，41 名居民有代理人同意（84%），8 名居民（16%）有医院非入院预先指示，37 名居民（82%）接受了至少 1 剂 COVID-19 疫苗。背景饮食中的硝酸盐摄入量<可接受的每日摄入量的 30%。34 名居民（76%）摄入了>50%的果汁。随机分配到硝酸盐组的居民尿液中的硝酸盐水平更高，中位数为 50 [18-175] 比 18 [10-50]mg/L，差值为 25 [0-90]mg/L。数据不足，无法进行临床组间比较；结果分布如下：无感染 32 例（67%），无并发症感染 0 例，需要医疗支持的感染 11 例（23%），全因住院 5 例（10%），全因死亡 0 例。最常见的感染是尿路感染。
结论
在 COVID-19 大流行期间，英国养老院的招募部分成功。补充膳食硝酸盐是可以耐受的，并能提高尿液中的硝酸盐水平。在 60 天内，33%的居民发生了感染、住院和死亡。现在需要进行更大规模的试验。
试验注册
ISRCTN51124684。申请日期 2020 年 12 月 7 日；分配日期 2021 年 1 月 13 日。
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