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Monday, March 26, 2012

Ergocalciferol Supplementation in Children with CKD Delays the Onset of Secondary Hyperparathyroidism: A Randomized Trial

Shroff R, Wan M, Gullett A, et al. Ergocalciferol Supplementation in Children with CKD Delays the Onset of Secondary Hyperparathyroidism: A Randomized Trial. Clin J Am Soc Nephrol. 2012 Feb;7(2):216-23. Epub 2012 Jan 19. (Original) PMID: 22266572

 Background and objectives Vitamin D deficiency is an important contributor to the development of hyperparathyroidism and is independently associated with cardiovascular and bone disease. The hypothesis was that nutritional vitamin D (ergocalciferol) supplementation in children with CKD stages 2-4 delays the onset of secondary hyperparathyroidism. Design, setting, participants, & measurements A randomized, double-blinded, placebo-controlled study in children with CKD2-4 who had 25-hydroxyvitamin D [25(OH)D] deficiency was conducted. Ergocalciferol (or a matched placebo) was given daily as per Kidney Disease Outcomes Quality Initiative guidelines. The primary endpoint was the time to development of hyperparathyroidism. Results Seventy-two children were screened. Forty-seven children were 25(OH)D-deficient and randomly assigned to receive ergocalciferol or placebo. Twenty children in each arm completed the study; median follow-up was 12 months. Groups were well matched for age, race, estimated GFR, and season when recruited. Nine of 20 children on placebo and 3 of 20 children on ergocalciferol developed hyperparathyroidism (odds ratio, 4.64; 95% confidence interval, 1.02-21.00). The time to development of hyperparathyroidism was significantly longer with ergocalciferol treatment compared with placebo (hazard ratio, 0.30; 95% confidence interval, 0.09-0.93, P=0.05). With ergocalciferol treatment, normal 25(OH)D levels were achieved in all 8 children with CKD2, 8 of 11 children with CKD3, but not in the single patient with CKD4. There were no ergocalciferol-related adverse events. 25(OH)D levels >100 nmol/L were required to achieve normal levels of 1,25-dihydroxyvitamin D. Conclusions Ergocalciferol is an effective treatment that delays the development of secondary hyperparathyroidism in children with CKD2-3.

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