title: A randomized controlled trial of cholecalciferol supplementation in patients on maintenance hemodialysis.
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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Senior Consultant, Division of Endocrinology and Diabetes, Kidney and Urology Institute, Gurgaon, Haryana, India.
authors.forename: Beena
authors.initials: B
authors.lastname: Bansal
authors.affiliation: Senior Consultant, Kidney and Urology Institute, Gurgaon, Haryana, India.
authors.forename: Shyam Bihari
authors.initials: SB
authors.lastname: Bansal
authors.affiliation: Chairman, Division of Endocrinology and Diabetes, Medanta, The Medicity, Gurgaon, Haryana, India.
authors.forename: Ambrish
authors.initials: A
authors.lastname: Mithal
authors.affiliation: Chairman, Kidney and Urology Institute, Gurgaon, Haryana, India.
authors.forename: Vijay
authors.initials: V
authors.lastname: Kher
authors.affiliation: Scientific Advisor, Institute of Life Sciences, Gurgaon, Haryana, India.
authors.forename: R
authors.initials: R
authors.lastname: Marwaha
authors.affiliation: Chief Statistical Advisor, Medanta Institute of Education and Research, Gurgaon, Haryana, India.
authors.forename: Padam
authors.initials: P
authors.lastname: Singh
authors.affiliation: Medical Officer, Chenab Hospital, Dulhasti Power Station, National Hydel Power Corporation Ltd., Kishtwar, Jammu and Kashmir, India.
authors.forename: Nasir
authors.initials: N
authors.lastname: Irfan
keywords: Cholecalciferol; India; chronic kidney disease; hemodialysis; vitamin D hemodialysis