Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial.

Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial.
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DOI:
10.1136/bmj-2021-066452
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发表时间:
2022-01-26
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Costenbader KH
Costenbader KH
中科院分区:
其他
文献类型:
--
作者:
Hahn J;Cook NR;Alexander EK;Friedman S;Walter J;Bubes V;Kotler G;Lee IM;Manson JE;Costenbader KH

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研究维生素D和海洋来源的长链欧米茄3脂肪酸是否能降低自身免疫性疾病的风险。维生素D和欧米茄3试验(VITAL),一项全国性的随机、双盲、安慰剂对照试验,采用2 × 2析因设计。在美国全国范围内。入组时有25,871名参与者,其中包括12,786名≥50岁的男性和13,085名≥55岁的女性。维生素D(2000 IU/天)或匹配的安慰剂,以及欧米茄3脂肪酸(1000 mg/天)或匹配的安慰剂。参与者自我报告了从基线到中位数为5.3年的随访期间发生的所有自身免疫性疾病;这些疾病通过广泛的医疗记录审查得到证实。考克斯比例风险模型用于测试维生素D和ω 3脂肪酸对自身免疫性疾病发病率的影响。主要终点是所有经病历审查证实的自身免疫性疾病:类风湿性关节炎、风湿性多肌痛、自身免疫性甲状腺疾病、银屑病和所有其他疾病。25871名参与者入组,中位随访5.3年。18 046人自称为非西班牙裔白色人,5106人自称为黑人,2152人自称为其他种族和民族。平均年龄为67.1岁。对于维生素D组,治疗组有123名参与者和安慰剂组有155名参与者患有确诊的自身免疫性疾病(风险比0.78,95%置信区间0.61至0.99,P=0.05)。在欧米茄3脂肪酸组中,治疗组有130名参与者,安慰剂组有148名参与者患有确诊的自身免疫性疾病(0.85,0.67至1.08,P=0.19)。与参考组相比(维生素D安慰剂和ω 3脂肪酸安慰剂; 88例确诊自身免疫性疾病),63例接受维生素D和欧米茄3脂肪酸治疗的参与者(0.69,0.49至0.96),60人只接受维生素D(0.68,0.48至0.94),67人只接受欧米茄3脂肪酸(0.74,0.54至1.03)已确认自身免疫性疾病。维生素D补充五年,有或没有ω 3脂肪酸,减少自身免疫性疾病22%,而ω 3脂肪酸补充或没有维生素D减少自身免疫性疾病率15%(无统计学意义)。两个治疗组均显示出比参考组(维生素D安慰剂和欧米茄3脂肪酸安慰剂)更大的效果。ClinicalTrials.gov NCT 01351805和NCT 01169259
To investigate whether vitamin D and marine derived long chain omega 3 fatty acids reduce autoimmune disease risk. Vitamin D and omega 3 trial (VITAL), a nationwide, randomized, double blind, placebo controlled trial with a two-by-two factorial design. Nationwide in the United States. 25 871 participants, consisting of 12 786 men ≥50 years and 13 085 women ≥55 years at enrollment. Vitamin D (2000 IU/day) or matched placebo, and omega 3 fatty acids (1000 mg/day) or matched placebo. Participants self-reported all incident autoimmune diseases from baseline to a median of 5.3 years of follow-up; these diseases were confirmed by extensive medical record review. Cox proportional hazard models were used to test the effects of vitamin D and omega 3 fatty acids on autoimmune disease incidence. The primary endpoint was all incident autoimmune diseases confirmed by medical record review: rheumatoid arthritis, polymyalgia rheumatica, autoimmune thyroid disease, psoriasis, and all others. 25 871 participants were enrolled and followed for a median of 5.3 years. 18 046 self-identified as non-Hispanic white, 5106 as black, and 2152 as other racial and ethnic groups. The mean age was 67.1 years. For the vitamin D arm, 123 participants in the treatment group and 155 in the placebo group had a confirmed autoimmune disease (hazard ratio 0.78, 95% confidence interval 0.61 to 0.99, P=0.05). In the omega 3 fatty acids arm, 130 participants in the treatment group and 148 in the placebo group had a confirmed autoimmune disease (0.85, 0.67 to 1.08, P=0.19). Compared with the reference arm (vitamin D placebo and omega 3 fatty acid placebo; 88 with confirmed autoimmune disease), 63 participants who received vitamin D and omega 3 fatty acids (0.69, 0.49 to 0.96), 60 who received only vitamin D (0.68, 0.48 to 0.94), and 67 who received only omega 3 fatty acids (0.74, 0.54 to 1.03) had confirmed autoimmune disease. Vitamin D supplementation for five years, with or without omega 3 fatty acids, reduced autoimmune disease by 22%, while omega 3 fatty acid supplementation with or without vitamin D reduced the autoimmune disease rate by 15% (not statistically significant). Both treatment arms showed larger effects than the reference arm (vitamin D placebo and omega 3 fatty acid placebo). ClinicalTrials.gov NCT01351805 and NCT01169259
DOI: 10.1210/er.2018-00126
发表时间: 2019-08-01
期刊: Endocrine reviews
影响因子: 20.3
作者:
Bouillon R;Marcocci C;Carmeliet G;Bikle D;White JH;Dawson-Hughes B;Lips P;Munns CF;Lazaretti-Castro M;Giustina A;Bilezikian J
通讯作者: Bilezikian J
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
DOI: 10.1371/journal.pone.0088103
发表时间: 2014
期刊: PloS one
影响因子: 3.7
作者:
Li K;Huang T;Zheng J;Wu K;Li D
通讯作者: Li D
DOI: 10.1006/clim.2000.4998
发表时间: 2001-04-01
影响因子: 8.6
作者:
Linker-Israeli, M;Elstner, E;Koeffler, HP
通讯作者: Koeffler, HP
DOI: 10.1373/clinchem.2019.306902
发表时间: 2019-12-01
期刊: CLINICAL CHEMISTRY
影响因子: 9.3
作者:
Costenbader, Karen H.;MacFarlane, Lindsey A.;Cook, Nancy R.
通讯作者: Cook, Nancy R.