维生素 D 补充与 2 型糖尿病预防。
Vitamin D Supplementation and Prevention of Type 2 Diabetes.
机构信息
From Tufts Medical Center (A.G.P., L.C., P.F., J.N., E.M.V.), the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (B.D.-H.), Brigham and Women's Hospital (V.R.A.), and Harvard School of Public Health (J.H.W.), Boston, and the Spaulding Rehabilitation Network, Charlestown (P.S.) - all in Massachusetts; National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ (W.C.K.); the Maine Medical Center (I.B.) and the Maine Medical Center Research Institute (C.R.) - both in Scarborough; HealthPartners Institute, Minneapolis (C.C.); Duke University Medical Center, Durham, NC (R.C., R.D.); the University of Nebraska Medical Center and Omaha Veterans Affairs Medical Center, Omaha (C.D.); Baylor College of Medicine, Houston (J.F.), and the University of Texas Southwestern Medical Center, Dallas (P.R.) - both in Texas; MedStar Good Samaritan Hospital, Baltimore (A.G.), MedStar Health Research Institute, Hyattsville (J.P.), and the National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda (M.S.) - all in Maryland; Pennington Biomedical Research Center, Baton Rouge, LA (D.S.H.); the University of Tennessee Health Science Center, Memphis (K.C.J.); Cleveland Clinic, Cleveland (S.R.K.); Stanford University Medical Center, Stanford (S.K.), and the Keck School of Medicine of the University of Southern California, Los Angeles (A.P.) - both in California; Kaiser Permanente Center for Health Research-Northwest, Portland, OR (E.S.L.); the University of Vermont, Burlington (M.R.L.); Northwell Health Lenox Hill Hospital, New York (E.L.); Northwestern University, Chicago (L.M.N.); the Medical University of South Carolina, Charleston (P.O.); Emory University School of Medicine, Atlanta, and the Atlanta Veterans Affairs Medical Center, Decatur - both in Georgia (L.S.P.); AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL (R.P.); the University of Colorado Denver and the Veterans Affairs Eastern Colorado Health Care System, Denver (N.R.); and the University of Kansas Medical Center, Kansas City (D.R.).
出版信息
N Engl J Med. 2019 Aug 8;381(6):520-530. doi: 10.1056/NEJMoa1900906. Epub 2019 Jun 7.
BACKGROUND
Observational studies support an association between a low blood 25-hydroxyvitamin D level and the risk of type 2 diabetes. However, whether vitamin D supplementation lowers the risk of diabetes is unknown.
METHODS
We randomly assigned adults who met at least two of three glycemic criteria for prediabetes (fasting plasma glucose level, 100 to 125 mg per deciliter; plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter; and glycated hemoglobin level, 5.7 to 6.4%) and no diagnostic criteria for diabetes to receive 4000 IU per day of vitamin D or placebo, regardless of the baseline serum 25-hydroxyvitamin D level. The primary outcome in this time-to-event analysis was new-onset diabetes, and the trial design was event-driven, with a target number of diabetes events of 508.
RESULTS
A total of 2423 participants underwent randomization (1211 to the vitamin D group and 1212 to the placebo group). By month 24, the mean serum 25-hydroxyvitamin D level in the vitamin D group was 54.3 ng per milliliter (from 27.7 ng per milliliter at baseline), as compared with 28.8 ng per milliliter in the placebo group (from 28.2 ng per milliliter at baseline). After a median follow-up of 2.5 years, the primary outcome of diabetes occurred in 293 participants in the vitamin D group and 323 in the placebo group (9.39 and 10.66 events per 100 person-years, respectively). The hazard ratio for vitamin D as compared with placebo was 0.88 (95% confidence interval, 0.75 to 1.04; P = 0.12). The incidence of adverse events did not differ significantly between the two groups.
CONCLUSIONS
Among persons at high risk for type 2 diabetes not selected for vitamin D insufficiency, vitamin D supplementation at a dose of 4000 IU per day did not result in a significantly lower risk of diabetes than placebo. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; D2d ClinicalTrials.gov number, NCT01942694.).
背景
观察性研究支持低血 25-羟维生素 D 水平与 2 型糖尿病风险之间存在关联。然而，维生素 D 补充是否降低糖尿病风险尚不清楚。
方法
我们随机分配符合至少三项血糖标准（空腹血糖 100-125mg/dL；口服葡萄糖负荷后 2 小时血糖 140-199mg/dL；糖化血红蛋白 5.7-6.4%）的成年人进行糖尿病前期的成年人接受每天 4000IU 的维生素 D 或安慰剂治疗，无论基线血清 25-羟维生素 D 水平如何。此次时间事件分析的主要结局为新发糖尿病，试验设计为事件驱动，目标糖尿病事件数为 508 例。
结果
共有 2423 名参与者接受了随机分组（1211 名接受维生素 D 组，1212 名接受安慰剂组）。到第 24 个月时，维生素 D 组的平均血清 25-羟维生素 D 水平为 54.3ng/ml（基线时为 27.7ng/ml），安慰剂组为 28.8ng/ml（基线时为 28.2ng/ml）。中位随访 2.5 年后，维生素 D 组有 293 名参与者和安慰剂组有 323 名参与者发生主要结局糖尿病（分别为每 100 人年 9.39 和 10.66 例）。与安慰剂相比，维生素 D 的风险比为 0.88（95%置信区间，0.75 至 1.04；P=0.12）。两组不良事件的发生率无显著差异。
结论
在未选择维生素 D 不足的 2 型糖尿病高危人群中，每天补充 4000IU 维生素 D 并未显著降低糖尿病风险。（由美国国立糖尿病、消化和肾脏疾病研究所等资助；D2d ClinicalTrials.gov 编号，NCT01942694.）
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