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高剂量维生素 D3 补充对改善 2 型糖尿病患者维生素 D 缺乏症的短期疗效 - 一项随机临床试验。

The short-term effect of high dose vitamin D3 supplementation in improving hypovitaminosis in patients with type 2 diabetes - A randomized clinical trial.

机构信息

Department of Clinical Biochemistry, Birjand University of Medical Sciences, Birjand, Iran.

Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences Mangalore,India. Manipal Academy of higher education, A constituent of MAHE,Manipal.

出版信息

Contemp Clin Trials. 2022 Jul;118:106769. doi: 10.1016/j.cct.2022.106769. Epub 2022 Apr 22.

Abstract

BACKGROUND

Type 2 diabetes (T2D) is an epidemic public health concern with considerable morbidity and mortality. Previous research has shown the association between T2D and vitamin D deficiency. This vitamin significantly affects insulin function, which plays a critical role in T2D development.

AIMS

A prospective double-blinded randomized controlled trial was conducted to test the hypothesis that vitamin D3 (VD3) supplementation can correct VD deficiency without the risk of hypervitaminosis.

METHODS

The participants of this study included 62 patients with T2D and hypovitaminosis D3. Of these patients, 30 received cholecalciferol (50,000 IU weekly for 8 weeks), and 32 received identical placebo tablets for 8 weeks. Before and after the intervention, patients were subjected to VD3 level assessment through fasting blood samples.

RESULTS

After 8 weeks of intervention, the mean changes in serum VD3 levels in the VD3 group were significant compared to the placebo group (i.e., 21.9 ± 10 vs. 1.2 ± 7 ng/ml, P < 0.001). Also, comparing serum D3 levels of the endpoint with the baseline revealed statistically significant changes in the VD3 group (40 ± 10 vs. 18.1 ± 6 ng/ml, P < 0.001) but no significant change in the placebo group (18.9 ± 7 vs. 20.1 ± 7, P = 0.37).

CONCLUSION

The results showed that administering a weekly dose of VD3 supplement could improve serum levels above 30 ng/ml in patients with T2D and compensate for vitamin deficiency without the risk of hypervitaminosis, which occurs at the levels above 100 ng/ml of 25(OH)D. However, further large-scale studies are needed to determine if these findings are applicable.

摘要

背景

2 型糖尿病(T2D)是一种具有相当发病率和死亡率的流行公共卫生问题。先前的研究表明,T2D 与维生素 D 缺乏之间存在关联。这种维生素对胰岛素功能有显著影响,而胰岛素在 T2D 的发展中起着关键作用。

目的

进行了一项前瞻性、双盲、随机对照试验,以检验以下假设,即维生素 D3(VD3)补充剂可以纠正 VD 缺乏而不会有发生维生素过多症的风险。

方法

本研究的参与者包括 62 名患有 T2D 和维生素 D3 缺乏症的患者。其中 30 名患者接受胆钙化醇(每周 50,000IU,持续 8 周)治疗,32 名患者接受相同的安慰剂片剂治疗 8 周。在干预前后,通过空腹血样评估患者的 VD3 水平。

结果

干预 8 周后,与安慰剂组相比,VD3 组的血清 VD3 水平平均变化显著(即 21.9±10 与 1.2±7ng/ml,P<0.001)。此外,与基线相比,VD3 组的血清 D3 水平终点也显示出统计学上的显著变化(40±10 与 18.1±6ng/ml,P<0.001),但安慰剂组没有显著变化(18.9±7 与 20.1±7,P=0.37)。

结论

结果表明,每周给予 VD3 补充剂可以提高 T2D 患者的血清水平至 30ng/ml 以上,并在不发生维生素过多症的情况下弥补维生素缺乏症,维生素过多症发生在 25(OH)D 水平高于 100ng/ml 时。然而,需要进一步的大规模研究来确定这些发现是否适用。

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