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维持性血液透析患者补充胆钙化醇的随机对照试验。

A randomized controlled trial of cholecalciferol supplementation in patients on maintenance hemodialysis.

作者信息

Bansal Beena, Bansal Shyam Bihari, Mithal Ambrish, Kher Vijay, Marwaha R, Singh Padam, Irfan Nasir

机构信息

Senior Consultant, Division of Endocrinology and Diabetes, Kidney and Urology Institute, Gurgaon, Haryana, India.

Senior Consultant, Kidney and Urology Institute, Gurgaon, Haryana, India.

出版信息

Indian J Endocrinol Metab. 2014 Sep;18(5):655-61. doi: 10.4103/2230-8210.139227.

DOI:10.4103/2230-8210.139227
PMID:25285282
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4171888/
Abstract

BACKGROUND

Vitamin D deficiency is common in Indian patients with chronic kidney disease (CKD) on maintenance hemodialysis (MHD), but optimal dose of cholecalciferol is unclear.

MATERIALS AND METHODS

A total of 45 consenting patients were randomized to intervention and control groups. In the intervention group, patients (n = 35) with serum 25-hydroxy vitamin D (25(OH)D) < 30 ng/mL (n = 33), received oral cholecalciferol 60,000 units/week for 6 weeks. The serum levels of 25(OH)D, calcium, phosphorus, albumin, and parathyroid hormone (PTH) were measured at 0, 6, and 12 weeks. In the control group (n = 10), these were estimated at 0 and 6 weeks.

RESULTS

In the intervention group, 25/35 patients completed the supplementation at 6 weeks and 20/35 were available at 12 weeks. The mean baseline level of 25(OH)D was 9.59 ± 7.59 ng/mL, and after 6 weeks 19.51 ± 4.27 ng/mL, mean increase being 9.99 ± 6.83 ng/mL, which was highly significant (P < 0.0001). After discontinuing supplementation at 6 weeks, serum 25(OH)D level dropped significantly from 6 to 12 weeks [-2.84 ± 6.25 ng/mL (P = 0.04)]. However, it was still significantly higher at 12 weeks (16.08 ± 8.27 ng/mL) as compared with the baseline. PTH and calcium did not change significantly with supplementation. The change in serum 25(OH)D level from baseline to 6 weeks in the intervention group was inversely related to baseline 25(OH)D levels and patient's weight. In the control group, change in 25(OH)D from baseline to 6 weeks was not significant.

CONCLUSION

Supplementation with cholecalciferol 60,000 unit/week for 6 weeks was insufficient to achieve optimal levels of 25(OH)D in Indian patients with CKD on MHD.

摘要

背景

在接受维持性血液透析(MHD)的印度慢性肾脏病(CKD)患者中,维生素D缺乏很常见,但胆钙化醇的最佳剂量尚不清楚。

材料与方法

共有45名同意参与的患者被随机分为干预组和对照组。在干预组中,血清25-羟维生素D(25(OH)D)<30 ng/mL的患者(n = 35)(n = 33),接受每周60,000单位的口服胆钙化醇,持续6周。在第0、6和12周测量血清25(OH)D、钙、磷、白蛋白和甲状旁腺激素(PTH)水平。在对照组(n = 10)中,在第0和6周进行这些指标的评估。

结果

在干预组中,25/35名患者在6周时完成了补充,20/35名患者在12周时仍可进行评估。25(OH)D的平均基线水平为9.59±7.59 ng/mL,6周后为19.51±4.27 ng/mL,平均升高9.99±6.83 ng/mL,差异具有高度显著性(P<0.0001)。在6周停止补充后,血清25(OH)D水平在6至12周显著下降[-2.84±6.25 ng/mL(P = 0.04)]。然而,与基线相比,在12周时仍显著更高(16.08±8.27 ng/mL)。补充后PTH和钙没有显著变化。干预组中血清25(OH)D水平从基线到6周的变化与基线25(OH)D水平和患者体重呈负相关。在对照组中,25(OH)D从基线到6周的变化不显著。

结论

对于接受MHD的印度CKD患者,每周补充60,000单位胆钙化醇持续6周不足以达到25(OH)D的最佳水平。

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