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维生素 D 和欧米伽-3 试验(VITAL):维生素 D 补充剂对美国人群跌倒风险的影响。

VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population.

机构信息

Division of Endocrinology, Diabetes and Hypertension, Department of Medicine, Brigham and Women's Hospital Boston, Massachusetts.

Harvard Medical School, Boston, Massachusetts.

出版信息

J Clin Endocrinol Metab. 2020 Sep 1;105(9):2929-38. doi: 10.1210/clinem/dgaa311.

DOI:10.1210/clinem/dgaa311
PMID:32492153
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7365686/
Abstract

CONTEXT

It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.

OBJECTIVE

The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.

DESIGN

VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median).

SETTING

This is a nationwide study.

PARTICIPANTS

Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study.

INTERVENTIONS

Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design.

MAIN OUTCOME MEASURES

Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit.

RESULTS

Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.

CONCLUSION

Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.

摘要

背景

目前尚不清楚维生素 D 补充剂是否能降低跌倒风险,且随机对照试验(RCT)的结果存在差异。

目的

本研究旨在确定每日补充 2000IU 维生素 D3 是否能降低跌倒风险。

设计

VITamin D 和 OmegA-3 TriaL(VITAL)是一项双盲、安慰剂对照 RCT,纳入了 25871 名成年人,于 2011 年 11 月至 2014 年 3 月随机分组,并接受了 5.3 年的治疗(中位时间)。

地点

这是一项全国性研究。

参与者

无基线癌症或心血管疾病的 50 岁及以上男性和 55 岁及以上女性(平均年龄 67.1 岁)参与了本研究。

干预措施

干预措施包括维生素 D3(胆钙化醇;每日 2000IU)和/或ω-3 脂肪酸(每日 1g)或相应的安慰剂,采用 2×2 析因设计。

主要结局指标

主要结局指标包括 2 次或以上跌倒和因跌倒导致看医生或住院。

结果

基线血清总 25-羟维生素 D(25[OH]D)水平为 77nmol/L;组间特征均衡。活跃组和安慰剂组的参与者中,2 次或以上跌倒的人数相似(9.8% vs 9.4%)。5 年内,两组之间发生 2 次或以上跌倒的比例无差异(优势比[OR] = 0.97;95%CI,0.90-1.05,P =.50)、跌倒导致看医生(OR = 1.03;95%CI,0.94-1.13,P =.46)或导致住院(OR = 1.04;95%CI,0.90-1.19,P =.61)的差异无统计学意义。25(OH)D 基线值<50 与≥50nmol/L 或其他切点的患者之间,结果无差异。

结论

与安慰剂相比,每日补充维生素 D3 并不能降低一般健康成年人的跌倒风险,这些成年人并非因维生素 D 缺乏而入选。本大型 RCT 并未表明在美国人群中,补充维生素 D 应用于跌倒的一级预防。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e98/7365686/d1cbd4b1de81/dgaa311f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e98/7365686/5a5e7211a9f1/dgaa311f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e98/7365686/d1cbd4b1de81/dgaa311f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e98/7365686/5a5e7211a9f1/dgaa311f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e98/7365686/d1cbd4b1de81/dgaa311f0002.jpg

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