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

• Published in: Clinical journal of the American Society of Nephrology Vol. 7; no. 2; pp. 216 - 223
• Main Authors: Shroff, Rukshana, Wan, Mandy, Gullett, Ambrose, Ledermann, Sarah, Shute, Rachel, Knott, Craig, Wells, David, Aitkenhead, Helen, Manickavasagar, Bahee, van't Hoff, William, Rees, Lesley
• Format: Journal Article
• Language: English
• Published: United States American Society of Nephrology 01.02.2012
• Subjects: Adolescent; Analysis of Variance; Biomarkers - blood; Chi-Square Distribution; Child; Child, Preschool; Chronic Disease; Dietary Supplements; Double-Blind Method; Ergocalciferols - therapeutic use; Female; Humans; Hyperparathyroidism, Secondary - blood; Hyperparathyroidism, Secondary - etiology; Hyperparathyroidism, Secondary - prevention & control; Kaplan-Meier Estimate; Kidney Diseases - blood; Kidney Diseases - complications; Kidney Diseases - drug therapy; London; Male; Odds Ratio; Placebos; Prospective Studies; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome; Vitamin D - analogs & derivatives; Vitamin D - blood; Vitamin D Deficiency - blood; Vitamin D Deficiency - complications; Vitamin D Deficiency - drug therapy; Vitamins - therapeutic use
• ISSN: 1555-9041; 1555-905X
• DOI: 10.2215/CJN.04760511

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. 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. 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. Ergocalciferol is an effective treatment that delays the development of secondary hyperparathyroidism in children with CKD2-3.