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Determining the optimal cholecalciferol dosing regimen in children with CKD: a randomized controlled trial

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Title: Determining the optimal cholecalciferol dosing regimen in children with CKD: a randomized controlled trial
Authors: Iyengar, Arpana, Kamath, Nivedita, Reddy, Hamsa V, Sharma, Jyoti, Singhal, Jyoti, Uthup, Susan, Ekambaram, Sudha, Selvam, Sumithra, Rahn, Anja, Fischer, Dagmar-C, Wan, Mandy, Shroff, Rukshana
Source: Nephrology Dialysis Transplantation. 37:326-334
Publisher Information: Oxford University Press (OUP), 2020.
Publication Year: 2020
Subject Terms: 2. Zero hunger, Chronic/complications, Vitamin D Deficiency, Hypercalcemia/complications, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Vitamin D Deficiency/blood, Parathyroid Hormone, Parathyroid Hormone/blood, Dietary Supplements, Hypercalcemia, Humans, Renal Insufficiency, Renal Insufficiency, Chronic, Child, Cholecalciferol/administration & dosage, Cholecalciferol
Description: Background The optimal treatment regimen for correcting 25-hydroxyvitamin D (25OHD) deficiency in children with chronic kidney disease (CKD) is not known. We compared cholecalciferol dosing regimens for achieving and maintaining 25OHD concentrations ≥30 ng/mL in children with CKD stages 2–4. Methods An open-label, multicentre randomized controlled trial randomized children with 25OHD concentrations Results Ninety children were randomized to daily (n = 30), weekly (n = 29) or monthly (n = 31) treatment groups. At the end of intensive phase, 70/90 (77.8%) achieved 25OHD ≥30 ng/mL; 25OHD concentrations were comparable between groups (median 44.3, 39.4 and 39.3 ng/mL for daily, weekly and monthly groups, respectively; P = 0.24) with no difference between groups for time to achieve 25OHD ≥30 ng/mL (P = 0.28). There was no change in calcium, phosphorus and parathyroid hormone, but fibroblast growth factor 23 (P = 0.002) and klotho (P = 0.001) concentrations significantly increased and were comparable in all treatment groups. Irrespective of dosing regimen, children with glomerular disease had 25OHD concentrations lower than non-glomerular disease (25.8 versus 41.8 ng/mL; P = 0.007). One child had a 25OHD concentration of 134 ng/mL, and 5.5% had hypercalcemia without symptoms of toxicity. Conclusion Intensive treatment with oral cholecalciferol as daily, weekly or monthly regimens achieved similar 25OHD concentrations between treatment groups, without toxicity. Children with glomerular disease required higher doses of cholecalciferol compared with those with non-glomerular disease.
Document Type: Article
Language: English
ISSN: 1460-2385
0931-0509
DOI: 10.1093/ndt/gfaa369
Access URL: https://pubmed.ncbi.nlm.nih.gov/33367869
https://www.ncbi.nlm.nih.gov/pubmed/33367869
https://pubmed.ncbi.nlm.nih.gov/33367869/
Rights: OUP Standard Publication Reuse
Accession Number: edsair.doi.dedup.....75ccaf79e31d9f58c7134947db1b107f
Database: OpenAIRE
Description
Abstract:Background The optimal treatment regimen for correcting 25-hydroxyvitamin D (25OHD) deficiency in children with chronic kidney disease (CKD) is not known. We compared cholecalciferol dosing regimens for achieving and maintaining 25OHD concentrations ≥30 ng/mL in children with CKD stages 2–4. Methods An open-label, multicentre randomized controlled trial randomized children with 25OHD concentrations Results Ninety children were randomized to daily (n = 30), weekly (n = 29) or monthly (n = 31) treatment groups. At the end of intensive phase, 70/90 (77.8%) achieved 25OHD ≥30 ng/mL; 25OHD concentrations were comparable between groups (median 44.3, 39.4 and 39.3 ng/mL for daily, weekly and monthly groups, respectively; P = 0.24) with no difference between groups for time to achieve 25OHD ≥30 ng/mL (P = 0.28). There was no change in calcium, phosphorus and parathyroid hormone, but fibroblast growth factor 23 (P = 0.002) and klotho (P = 0.001) concentrations significantly increased and were comparable in all treatment groups. Irrespective of dosing regimen, children with glomerular disease had 25OHD concentrations lower than non-glomerular disease (25.8 versus 41.8 ng/mL; P = 0.007). One child had a 25OHD concentration of 134 ng/mL, and 5.5% had hypercalcemia without symptoms of toxicity. Conclusion Intensive treatment with oral cholecalciferol as daily, weekly or monthly regimens achieved similar 25OHD concentrations between treatment groups, without toxicity. Children with glomerular disease required higher doses of cholecalciferol compared with those with non-glomerular disease.
ISSN:14602385
09310509
DOI:10.1093/ndt/gfaa369