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

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

Beena Bansal  1 , Shyam Bihari Bansal  2 , Ambrish Mithal  3 , Vijay Kher  4 , R Marwaha  5 , Padam Singh  6 , Nasir Irfan  7
Affiliations

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

Beena Bansal et al. Indian J Endocrinol Metab. 2014 Sep.

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.

Keywords: Cholecalciferol; India; chronic kidney disease; hemodialysis; vitamin D hemodialysis.

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Conflict of interest statement

Conflict of Interest: No.

Figures

Figure 1
Figure 1
Study design. *Biochemistry included serum calcium, phosphuros, alkaline phosphatase, hemoglobin, albumin, 25-hydroxy vitamin D and intact PTH
Figure 2
Figure 2
Number of patients who were vitamin D deficient, insufficient and sufficient at baseline, 6 weeks and 12 weeks in the intervention group
Figure 3
Figure 3
Correlation between baseline 25-hydroxy vitamin D and change in 25(OH) vitamin D after cholecalciferol supplementation 60,000 units weekly from baseline to 6 weeks
See this image and copyright information in PMC

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