Effect of Vitamin D3 and Omega-3 Fatty Acid Supplementation on Risk of Frailty: An Ancillary Study of a Randomized Clinical Trial.
Effect of Vitamin D3 and Omega-3 Fatty Acid Supplementation on Risk of Frailty: An Ancillary Study of a Randomized Clinical Trial.
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补充维生素D3和Omega-3脂肪酸对虚弱风险的影响：一项随机临床试验的辅助研究。
DOI：
10.1001/jamanetworkopen.2022.31206
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发表时间：
2022-09-01
影响因子：
13.8
通讯作者：
Manson, JoAnn E.
中科院分区：
文献类型：
--
作者：
Orkaby, Ariela R.;Dushkes, Rimma;Ward, Rachel;Djousse, Luc;Buring, Julie E.;Lee, I-Min;Cook, Nancy R.;LeBoff, Meryl S.;Okereke, Olivia, I;Copeland, Trisha;Manson, JoAnn E.
补充维生素D3和/或omega-3脂肪酸是否可以降低虚弱的风险？在这项随机临床试验的辅助研究中，包括25871名年龄在50岁或以上的个体，与安慰剂相比，维生素D3，2000 IU/d，也不是omega-3脂肪酸，1 g/d，补充剂，在5年的治疗期间显着影响虚弱评分的变化。使用虚弱身体表型的结果没有变化。这项辅助研究的结果不支持在社区居住的老年人中常规使用维生素D3或omega-3脂肪酸补充剂来预防虚弱。需要制定脆弱的预防策略。具有抗炎特性的补充剂（例如维生素D3或海洋欧米茄-3脂肪酸）是否有助于预防虚弱尚不清楚。测试维生素D3和omega-3补充剂对老年人虚弱变化的影响。这项研究于2021年进行，作为维生素D和Omega-3（VITAL）试验（一项2 × 2析因随机临床试验）的预先指定辅助研究。从2011年11月至2014年3月，在美国所有50个州共招募了25871名无癌症或心血管疾病且有虚弱数据的个体（男性年龄≥50岁，女性年龄≥55岁），并随访至2017年12月31日。辅助研究的数据分析于2019年12月1日至2022年3月30日进行。维生素D3，2000 IU/d，海洋欧米茄-3脂肪酸，1 g/d。采用经验证的36项虚弱指数测量虚弱程度，该指数包括年度问卷中的功能、认知、情绪和合并症。根据随机化，使用意向治疗方案，使用重复测量评估虚弱评分从基线到第5年的变化。考克斯比例风险回归模型评估事件脆弱性。在亚组分析中，使用另一种虚弱定义（身体表型）作为敏感性分析。在随机分配的25871名VITAL试验参与者中，25057人有足够的数据来计算虚弱指数。基线平均（SD）年龄为67.2（7.0）岁，都是女人平均（SD）虚弱评分为0.109（0.090）（范围：0.00-0.685），3174人（12.7%）虚弱。在中位5年随访期间，平均（SD）虚弱评分增加至0.121（0.099）（范围，0.00-0.792）。补充维生素D3和omega-3脂肪酸都不会影响平均虚弱评分（第5年的平均差异：维生素D3，-0.0002; P = .85; ω-3脂肪酸，-0.0001; P = .90）或平均虚弱评分的变化率（与时间的相互作用：维生素D3; P = 0.98; ω-3脂肪酸; P = 0.13）随时间推移，偶发虚弱保持相似（与时间的相互作用：维生素D3，P = 0.90; ω-3脂肪酸; P = 0.32）。使用虚弱身体表型的结果没有变化。在这项VITAL随机临床试验的辅助研究中，与安慰剂相比，维生素D3或omega-3脂肪酸补充剂治疗并没有影响虚弱的变化率或发病率。这些结果不支持在一般健康的社区居住老年人中常规使用维生素D3或omega-3脂肪酸补充剂预防虚弱，而不是选择维生素D3缺乏症。ClinicalTrials.gov 标识符：NCT 01169259这项随机临床试验的辅助研究调查了维生素D3与omega-3脂肪酸补充剂对老年人虚弱的影响。
Does supplementation with vitamin D3 and/or omega-3 fatty acids reduce the risk of frailty? In this ancillary study of a randomized clinical trial including 25 871 individuals aged 50 years or older, neither vitamin D3, 2000 IU/d, nor omega-3 fatty acid, 1 g/d, supplementation, compared with placebo, significantly affected change in frailty score during 5 years of treatment. Results were unchanged using the frailty physical phenotype. The results of this ancillary study do not support the routine use of vitamin D3 or omega-3 fatty acid supplementation in community-dwelling older adults for the prevention of frailty. Preventive strategies for frailty are needed. Whether supplements with anti-inflammatory properties, such as vitamin D3 or marine omega-3 fatty acids, are useful for frailty prevention is unknown. To test the effects of vitamin D3 and omega-3 supplements on change in frailty in older individuals. This study was conducted in 2021, as a prespecified ancillary to the Vitamin D and Omega-3 (VITAL) trial, a 2 × 2 factorial randomized clinical trial. A total of 25 871 individuals (men aged ≥50 years and women aged ≥55 years), without cancer or cardiovascular disease and with data on frailty, were recruited across all 50 US states from November 2011 to March 2014 and followed up through December 31, 2017. Data analysis for the ancillary study was conducted from December 1, 2019, to March 30, 2022. Vitamin D3, 2000 IU/d, and marine omega-3 fatty acids, 1 g/d. Frailty was measured using a validated 36-item frailty index that includes measures of function, cognition, mood, and comorbidities from annual questionnaires. Change in frailty score from baseline to year 5, according to randomization, using an intention-to-treat protocol, was assessed using repeated measures. Cox proportional hazards regression models assessed incident frailty. In subgroup analysis, an alternative frailty definition, the physical phenotype, was used as a sensitivity analysis. Of 25 871 VITAL trial participants randomized, 25 057 had sufficient data to calculate a frailty index. Baseline mean (SD) age was 67.2 (7.0) years, and 12 698 (50.7.%) were women. Mean (SD) frailty score was 0.109 (0.090) (range, 0.00-0.685), and 3174 individuals (12.7%) were frail. During a median 5-year follow-up, mean (SD) frailty scores increased to 0.121 (0.099) (range, 0.00-0.792). Neither vitamin D3 nor omega-3 fatty acid supplementation affected mean frailty scores over time (mean difference at year 5: vitamin D3, −0.0002; P = .85; omega-3 fatty acid, −0.0001; P = .90) or rate of change in mean frailty score (interaction with time: vitamin D3; P = .98; omega-3 fatty acid; P = .13) Incident frailty remained similar over time (interaction with time: vitamin D3, P = .90; omega-3 fatty acid; P = .32). Results were unchanged using the frailty physical phenotype. In this ancillary study of the VITAL randomized clinical trial, treatment with vitamin D3 or omega-3 fatty acid supplementation, compared with placebo, did not affect the rate of frailty change or incidence over time. These results do not support routine use of either vitamin D3 or omega-3 fatty acid supplementation for frailty prevention in generally healthy community-dwelling older adults not selected for vitamin D3 deficiency. ClinicalTrials.gov Identifier: NCT01169259 This ancillary study of a randomized clinical trial investigates the effects of vitamin D3 with omega-3 fatty acid supplementation on frailty in older adults.
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影响因子：
64.5
作者：
López-Otín C;Blasco MA;Partridge L;Serrano M;Kroemer G
通讯作者：
Kroemer G
海洋N-3脂肪酸和心血管疾病和癌症的预防。
DOI：
10.1056/nejmoa1811403
发表时间：
2019-01-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Manson JE;Cook NR;Lee IM;Christen W;Bassuk SS;Mora S;Gibson H;Albert CM;Gordon D;Copeland T;D'Agostino D;Friedenberg G;Ridge C;Bubes V;Giovannucci EL;Willett WC;Buring JE;VITAL Research Group
通讯作者：
VITAL Research Group
影响因子：
9.3
作者：
Chong ZZ;Shang YC;Maiese K
通讯作者：
Maiese K
影响因子：
4.4
作者：
Dodds, Richard;Sayer, Avan Aihie
通讯作者：
Sayer, Avan Aihie
影响因子：
4
作者：
Dupont, Jolan;Dedeyne, Lenore;Gielen, Evelien
通讯作者：
Gielen, Evelien