Ergocalciferol supplementation in children with CKD delays the onset of secondary hyperparathyroidism: a randomized trial.

Abstract

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.

• Authors: Rukshana Shroff, Mandy Wan, Ambrose Gullett, Sarah Ledermann, Rachel Shute, Craig Knott, David Wells, Helen Aitkenhead, Bahee Manickavasagar, William van't Hoff, Lesley Rees
• Journal: Clinical journal of the American Society of Nephrology : CJASN (Clin J Am Soc Nephrol) Vol. 7 Issue 2 Pg. 216-23 (Feb 2012) ISSN: 1555-905X [Electronic] United States
• PMID: 22266572 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Biomarkers
• Ergocalciferols
• Placebos
• Vitamins
• Vitamin D
• 25-hydroxyvitamin D

Topics

• 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, etiology, prevention & control)
• Kaplan-Meier Estimate
• Kidney Diseases (blood, complications, drug therapy)
• London
• Male
• Odds Ratio
• Placebos
• Prospective Studies
• Risk Assessment
• Risk Factors
• Time Factors
• Treatment Outcome
• Vitamin D (analogs & derivatives, blood)
• Vitamin D Deficiency (blood, complications, drug therapy)
• Vitamins (therapeutic use)