EFFECT OF HIGH-DOSE VITAMIN D REPLETION ON GLYCEMIC CONTROL IN AFRICAN-AMERICAN MALES WITH PREDIABETES AND HYPOVITAMINOSIS D.
EFFECT OF HIGH-DOSE VITAMIN D REPLETION ON GLYCEMIC CONTROL IN AFRICAN-AMERICAN MALES WITH PREDIABETES AND HYPOVITAMINOSIS D.
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DOI：
10.4158/ep14548.or
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发表时间：
2015-06
期刊：
影响因子：
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通讯作者：
Ciubotaru I
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作者：
Barengolts E;Manickam B;Eisenberg Y;Akbar A;Kukreja S;Ciubotaru I
这项双盲、随机、对照试验评估了12个月大剂量维生素D2补充剂对改善胰岛素敏感性、分泌和血糖状态的作用。患有糖尿病前期（A1C 5.7 - 6.4%）、维生素缺乏症D （25OHD 5 - 29 ng/ml）和常见医学问题的非洲裔美国男性补充维生素D3 （400 IU/天），然后随机分为每周安慰剂组或维生素D2组（50,000 IU）。主要终点是治疗12个月后口服葡萄糖胰岛素敏感性（OGIS，来自口服葡萄糖耐量试验）的变化。次要结局包括其他血糖指标、糖化血红蛋白和糖尿病。补充维生素d （n = 87）和安慰剂（n = 86）的受试者完成试验的基线特征相似，25OHD、OGIS和A1C的平均浓度分别为14.4 ng/ml、362 ng/ml和6.1%。12个月后，维生素d补充组血清25OHD +35 vs安慰剂组+6 ng/ml， p<0.001；OGIS为+7.8 vs安慰剂为- 16.0,p = 0.026；糖化血红蛋白- 0.01 vs安慰剂组+0.01%,p = 0.66；两组均有10%的人发展为糖尿病。对基线空腹血糖受损参与者的事后分析显示，维生素D亚组（31.6%）比安慰剂组（8.3%）更多的受试者恢复到正常的葡萄糖耐量，但差异没有达到显著性（p=0.13）。该试验没有提供证据表明12个月的高剂量D2补充可以改善糖尿病前期和维生素D缺乏症患者的临床相关血糖结局（NCT01375660）。
This double blind, randomized, controlled trial evaluated 12 months high dose vitamin D2 supplementation for improving insulin sensitivity, secretion and glycemic status. African American men with prediabetes (A1C 5.7 – 6.4%), hypovitaminosis D (25OHD 5 – 29 ng/ml), and prevalent medical problems were supplemented with vitamin D3 (400 IU/day) and then randomized to weekly placebo or vitamin D2 (50,000 IU). The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment. Secondary outcomes included other glycemic indices, A1C and incident diabetes. Baseline characteristics were similar in vitamin D-supplemented (n = 87) and placebo (n = 86) subjects completing the trial with average concentrations 14.4 ng/ml, 362 and 6.1% for 25OHD, OGIS and A1C, respectively. After 12 months vitamin D-supplemented group had a change in serum 25OHD +35 vs +6 ng/ml for placebo, p<0.001; OGIS +7.8 vs −16.0 for placebo, p = 0.026; and A1C −0.01 vs +0.01% for placebo, p = 0.66; while 10% in both groups progressed to diabetes. A post hoc analysis of participants with baseline impaired fasting glucose showed that more subjects in the vitamin D subgroup (31.6%) than placebo (8.3%) returned to normal glucose tolerance, but the difference did not reach significance (p=0.13). The trial does not provide evidence that 12 months of high-dose D2 repletion improves clinically relevant glycemic outcomes in subjects with prediabetes and hypovitaminosis D (NCT01375660).