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Ergocalciferol supplementation in children with CKD delays the onset of secondary hyperparathyroidism: a randomized
Rukshana Shroff1, Mandy Wan, Ambrose Gullett
1Renal Unit, Ormond Street Hospital for Children NHS Trust and Institute of Child Health, London WC1N 3JH, UK. Rukshana.Shroff@gosh.nhs.uk
Insights
Vitamin D (ergocalciferol) supplementation effectively delays secondary hyperparathyroidism in children with chronic kidney disease (CKD) stages 2-3. This treatment is safe and helps maintain sufficient vitamin D levels.
Area of Science:
- Pediatric Nephrology
- Endocrinology
- Nutritional Science
Background:
- Vitamin D deficiency is a significant factor in hyperparathyroidism development.
- It is also independently linked to cardiovascular and bone diseases.
- Children with chronic kidney disease (CKD) are particularly susceptible to these complications.
Purpose of the Study:
- To investigate if nutritional vitamin D (ergocalciferol) supplementation can delay secondary hyperparathyroidism in children with CKD stages 2-4.
- To assess the efficacy and safety of ergocalciferol in this pediatric population.
Main Methods:
- A randomized, double-blinded, placebo-controlled trial was conducted.
- Participants included children with CKD stages 2-4 and confirmed 25-hydroxyvitamin D [25(OH)D] deficiency.
- Ergocalciferol or a placebo was administered daily, with the primary endpoint being the time to hyperparathyroidism development.
Main Results:
- Nine out of 20 children on placebo developed hyperparathyroidism, compared to 3 out of 20 on ergocalciferol.
- Ergocalciferol significantly increased the time to hyperparathyroidism onset (P=0.05).
- Normal 25(OH)D levels were achieved in most children with CKD2-3, but not in the single CKD4 patient.
Conclusions:
- Ergocalciferol is an effective treatment for delaying secondary hyperparathyroidism in children with CKD stages 2-3.
- The treatment was well-tolerated with no reported adverse events.
- Achieving normal 1,25-dihydroxyvitamin D levels requires 25(OH)D levels above 100 nmol/L.
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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