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ORIGINAL ARTICLE
Year : 2014  |  Volume : 18  |  Issue : 5  |  Page : 655-661

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


1 Senior Consultant, Division of Endocrinology and Diabetes, Kidney and Urology Institute, Gurgaon, Haryana, India
2 Senior Consultant, Kidney and Urology Institute, Gurgaon, Haryana, India
3 Chairman, Division of Endocrinology and Diabetes, Medanta, The Medicity, Gurgaon, Haryana, India
4 Chairman, Kidney and Urology Institute, Gurgaon, Haryana, India
5 Scientific Advisor, Institute of Life Sciences, Gurgaon, Haryana, India
6 Chief Statistical Advisor, Medanta Institute of Education and Research, Gurgaon, Haryana, India
7 Medical Officer, Chenab Hospital, Dulhasti Power Station, National Hydel Power Corporation Ltd., Kishtwar, Jammu and Kashmir, India

Correspondence Address:
Dr. Beena Bansal
Division of Endocrinology and Diabetes, Medanta, the Medicity, Sector 39, Gurgaon - 122 001, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2230-8210.139227

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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.


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