Diabetes Research Institute, Forschergruppe Diabetes eV, Munich, Germany.
Diabetes Care. 2010 Jul;33(7):1443-8. doi: 10.2337/dc09-2297. Epub 2010 Mar 31.
To determine whether daily intake of 1alpha,25-dihydroxyvitamin D(3) [1,25(OH)(2)D(3)] is safe and improves beta-cell function in patients with recently diagnosed type 1 diabetes.
Safety was assessed in an open study of 25 patients aged 18-39 years with recent-onset type 1 diabetes who received 0.25 microg 1,25(OH)(2)D(3) daily for 9 months. An additional 40 patients were randomly assigned to 0.25 microg 1,25(OH)(2)D(3) or placebo daily for 9 months and followed for a total of 18 months for safety, beta-cell function, insulin requirement, and glycemic control.
Safety assessment showed values in the normal range in nearly all patients, regardless of whether they received 1,25(OH)(2)D(3) or placebo. No differences in AUC C-peptide, peak C-peptide, and fasting C-peptide after a mixed-meal tolerance test between the treatment and placebo groups were observed at 9 and 18 months after study entry, with approximately 40% loss for each parameter over the 18-month period. A1C and daily insulin requirement were similar between treatment and placebo groups throughout the study follow-up period.
Treatment with 1,25(OH)(2)D(3) at a daily dose of 0.25 microg was safe but did not reduce loss of beta-cell function.
确定每日摄入 1α,25-二羟维生素 D(3) [1,25(OH)(2)D(3)] 是否安全，并改善新近诊断为 1 型糖尿病患者的胰岛β细胞功能。
在一项开放性研究中，对 25 名年龄在 18-39 岁的新近诊断为 1 型糖尿病的患者进行安全性评估，这些患者每天接受 0.25μg 1,25(OH)(2)D(3)治疗，为期 9 个月。另外 40 名患者被随机分配至每天接受 0.25μg 1,25(OH)(2)D(3)或安慰剂治疗，并随访 18 个月，以评估安全性、胰岛β细胞功能、胰岛素需求和血糖控制情况。
安全性评估显示，无论患者接受 1,25(OH)(2)D(3)还是安慰剂治疗，几乎所有患者的检测值均在正常范围内。在研究开始后 9 个月和 18 个月时，混合餐耐量试验后 AUC C-肽、峰值 C-肽和空腹 C-肽在治疗组和安慰剂组之间无差异，18 个月期间每个参数均有约 40%的损失。A1C 和每日胰岛素需求在整个研究随访期间在治疗组和安慰剂组之间相似。
以每天 0.25μg 的剂量使用 1,25(OH)(2)D(3)治疗是安全的，但不会减少胰岛β细胞功能的丧失。
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