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Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes
JAMA ( IF 63.1 ) Pub Date : 2019-11-19 , DOI: 10.1001/jama.2019.17380
Ian H de Boer 1, 2, 3 , Leila R Zelnick 1, 2 , John Ruzinski 2 , Georgina Friedenberg 4 , Julie Duszlak 4 , Vadim Y Bubes 4 , Andrew N Hoofnagle 1, 5 , Ravi Thadhani 6 , Robert J Glynn 4, 7 , Julie E Buring 4, 7 , Howard D Sesso 4, 7 , JoAnn E Manson 4, 7
Affiliation  

Importance Chronic kidney disease (CKD) is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes. Objective To test whether supplementation with vitamin D3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes. Design, Setting, and Participants Randomized clinical trial with a 2 × 2 factorial design conducted among 1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial (VITAL), coordinated by a single center in Massachusetts. Follow-up was completed in December 2017. Interventions Participants were randomized to receive vitamin D3 (2000 IU/d) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid; 1 g/d) (n = 370), vitamin D3 and placebo (n = 333), placebo and omega-3 fatty acids (n = 289), or 2 placebos (n = 320) for 5 years. Main Outcomes and Measures The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR) from baseline to year 5. Results Among 1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study. Baseline mean eGFR was 85.8 (SD, 22.1) mL/min/1.73 m2. Mean change in eGFR from baseline to year 5 was -12.3 (95% CI, -13.4 to -11.2) mL/min/1.73 m2 with vitamin D3 vs -13.1 (95% CI, -14.2 to -11.9) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.5] mL/min/1.73 m2). Mean change in eGFR was -12.2 (95% CI, -13.3 to -11.1) mL/min/1.73 m2 with omega-3 fatty acids vs -13.1 (95% CI, -14.2 to -12.0) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.6] mL/min/1.73 m2). There was no significant interaction between the 2 interventions. Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo). Conclusions and Relevance Among adults with type 2 diabetes, supplementation with vitamin D3 or omega-3 fatty acids, compared with placebo, resulted in no significant difference in change in eGFR at 5 years. The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes. Trial Registration ClinicalTrials.gov Identifier: NCT01684722.

中文翻译:

维生素 D 和 Omega-3 脂肪酸补充剂对 2 型糖尿病患者肾功能的影响

重要性 慢性肾病 (CKD) 是 2 型糖尿病的常见并发症,可导致终末期肾病,并与高心血管风险相关。很少有治疗方法可用于预防 2 型糖尿病患者的 CKD。目的 测试补充维生素 D3 或 omega-3 脂肪酸是否可以防止 2 型糖尿病患者 CKD 的发展或进展。设计、设置和参与者 2011 年 11 月至 2014 年 3 月期间从美国所有 50 个州招募的 1312 名患有 2 型糖尿病的成年人进行 2 × 2 因子设计的随机临床试验,作为维生素 D 和 Omega-3 试验的辅助研究。 VITAL),由马萨诸塞州的一个中心协调。随访于 2017 年 12 月完成。干预 参与者被随机分配接受维生素 D3(2000 IU/d)和 omega-3 脂肪酸(二十碳五烯酸和二十二碳六烯酸;1 g/d)(n = 370)、维生素 D3 和安慰剂(n = 333)、安慰剂和omega-3 脂肪酸 (n = 289) 或 2 种安慰剂 (n = 320) 5 年。主要结果和测量 主要结果是根据血清肌酐和胱抑素 C (eGFR) 估算的肾小球滤过率从基线到第 5 年的变化。结果在 1312 名随机参与者中(平均年龄 67.6 岁;46% 的女性;31% 的种族或少数民族),934 人(71%)完成了研究。基线平均 eGFR 为 85.8 (SD, 22.1) mL/min/1.73 m2。从基线到第 5 年,eGFR 的平均变化为 -12.3(95% CI,-13.4 至 -11.2)mL/min/1.73 m2,维生素 D3 对比 -13.1(95% CI,-14.2 至 -11.9)mL/min/ 1.73 m2 与安慰剂(差异,0.9 [95% CI,-0.7 至 2。5] 毫升/分钟/1.73 平方米)。eGFR 的平均变化为 -12.2(95% CI,-13.3 至 -11.1)mL/min/1.73 m2,omega-3 脂肪酸与 -13.1(95% CI,-14.2 至 -12.0)mL/min/1.73 m2与安慰剂组(差异,0.9 [95% CI,-0.7 至 2.6] mL/min/1.73 m2)。两种干预措施之间没有显着的相互作用。58 名参与者(n = 32 接受维生素 D3,n = 26 接受安慰剂)发生肾结石,45 人出现胃肠道出血(n = 28 接受 omega-3 脂肪酸,n = 17 接受安慰剂)。结论和相关性 在患有 2 型糖尿病的成年人中,与安慰剂相比,补充维生素 D3 或 omega-3 脂肪酸在 5 年时 eGFR 的变化没有显着差异。研究结果不支持使用维生素 D 或 omega-3 脂肪酸补充剂来保护 2 型糖尿病患者的肾功能。试验注册 ClinicalTrials.gov 标识符:NCT01684722。
更新日期:2019-11-19
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