美国华盛顿大学Ian H. de Boer联合布列根和妇女医院JoAnn E. Manson研究组，探讨了补充维生素D和ω-3脂肪酸对2型糖尿病患者肾功能的影响。这一研究成果于2019年11月8日发表在《美国医学会杂志》上。

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，且与较高的心血管风险相关。目前鲜有方法来预防2型糖尿病CKD。

2011年11月至2014年3月，研究组从美国的50个州招募了1312名2型糖尿病成人患者，采用2×2因子设计，进行随机临床试验。其中370例患者口服维生素D3 + ω-3脂肪酸，333例口服维生素D3 + 安慰剂，289例口服ω-3脂肪酸 + 安慰剂，320例口服2种安慰剂，所有患者均治疗5年。根据血清肌酐和胱抑素C来估计肾小球滤过率（eGFR）。

共有934人（71%）完成了该试验，基线时的平均eGFR为85.8 mL/min/1.73m²。治疗第5年，维生素D3组的eGFR平均降低了12.3 mL/min/1.73m²，ω-3脂肪酸组降低了12.2 mL/min/1.73m²，安慰剂组则降低了13.1 mL/min/1.73m²。两种干预方法之间并无显著交互作用。

共有58例患者出现肾结石，其中维生素D3组32例，安慰剂组26例；45例患者出现消化道出血，其中ω-3脂肪酸组28例，安慰剂组17例。

总之，成人2型糖尿病患者口服维生素D3或ω-3脂肪酸，与安慰剂相比，5年后eGFR并无显著差异。研究结果不支持2型糖尿病患者服用维生素D3或ω-3脂肪酸来维持肾功能。

附：英文原文

Title: Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial

Author: Ian H. de Boer, Leila R. Zelnick, John Ruzinski, Georgina Friedenberg, Julie Duszlak, Vadim Y. Bubes, Andrew N. Hoofnagle, Ravi Thadhani, Robert J. Glynn, Julie E. Buring, Howard D. Sesso, JoAnn E. Manson

Issue&Volume: November 8, 2019

Abstract:

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.

DOI: 10.1001/jama.2019.17380

Source: https://jamanetwork.com/journals/jama/article-abstract/2755300