Determining the Optimal Dose of Cholecalciferol Supplementation for Children with CKD (C<sub>3</sub> Trial): An Open-Label Multicentre Randomized Controlled Trial
October 22, 2020 | 10:00 AM - 12:00 PM
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Determining the Optimal Dose of Cholecalciferol Supplementation for Children with CKD (C3 Trial): An Open-Label Multicentre Randomized Controlled Trial
- Pediatric Nephrology: Benign Urology, AKI, Neonatal Nephrology, and Case Reports
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Pediatric Nephrology
- 1700 Pediatric Nephrology
- Iyengar, Arpana A., St John's Medical College Hospital, Bangalore, Karnataka, India
- Kamath, Nivedita, St John's Medical College Hospital, Bangalore, Karnataka, India
- V, Hamsa, St John's Medical College Hospital, Bangalore, Karnataka, India
- Uthup, Susan, Government medical College Hospital, Trivandrum, Kerala, India
- Sharma, Jyoti, KEM Hospital,Pune, Pune, Maharashtra, India
- Singhal, Jyoti S., KEM Hospital,Pune, Pune, Maharashtra, India
- Ekambaram, Sudha, Mehta Hospitals, Chennai, Tamil Nadu, India
- Wan, Mandy, Great Ormond Hospital for Children, London, London, United Kingdom
- Shroff, Rukshana, Great Ormond Hospital for Children, London, London, United Kingdom
Arpana A. Iyengar,
Jyoti S. Singhal,
The optimal treatment regimen for correcting 25-hydroxyvitamin D (25OHD) deficiency in children with CKD has not been established. We studied oral cholecalciferol treatment regimens that achieve and maintain 25OHD levels above 30ng/ml in children with CKD stages 2-4.
We performed an open label, multicentre randomized controlled trial in children with 25OHD <30ng/ml, randomized 1:1:1 to oral cholecalciferol as 3000IU daily, 25,000IU weekly or 100,000IU monthly for 3months intensive phase therapy. A maximum of 3 courses of intensive phase treatment were allowed if 25OHD was <30ng/ml. Patients achieving normal 25OHD entered maintenance phase with 1000IU cholecalciferol daily for 9 months. Primary outcome was achieving 25OHD levels ≥30 ng/ml at end of intensive phase therapy.
Of the 150 children screened, 90 were 25OHD deficient and randomised to daily(n=30),weekly(n=29) or monthly(n=31) treatment arms. Age, gender, renal disease, eGFR and baseline 25OHD were comparable between treatment arms. At end of the intensive phase 68.8% achieved 25OHD ≥30ng/ml with comparable levels between arms(median 44.3 39.4 and 39.3 ng/ml p=0.24) on daily,weekly,monthly regimens respectively. The time taken to achieve 25OHD ≥30 ng/ml was comparable between treatment arms (p=0.28) with 7.7% not achieving normal 25OHD after 3 courses. Irrespective of treatment arm, median 25OHD were lower in children with glomerular disease than non-glomerular disease [25.8 vs 41.8ng/ml; p=0.007]. There was no significant difference in 25OHD between treatment arms at end of intensive(p=0.24) or maintenance phase therapy (p>0.05)[Figure]. There was no hypercalcaemia or hypercalciuria.
Intensive phase therapy with oral cholecalciferol as daily, weekly or monthly regimens achieved similar 25OHD levels without toxicity. Children with glomerular disease require higher doses of cholecalciferol compared to non-glomerular disease.