Determining the optimal cholecalciferol dosing regimen in children with CKD: a randomized controlled trial
Iyengar A, Kamath N, Reddy HV, Sharma J, Singhal J, Uthup S, Ekambaram S, Selvam S, Rahn A, Fischer DC, Wan M, Shroff R
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 11 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- National Institute on Handicapped Research
- Government
- National Institute for Health and Care Research
- Nonprofit
- Kidney Research UK
- University or hospital
- KEM Hospital Research Centre
- Government
- National Institute for Health Research (NIHR)
- Government
- UK National Institute for Health Research
- Nonprofit
- Navajbai Ratan Tata Trust
- Government
- NIHR Clinical Doctoral Research Fellowship
- Grants
- Kidney Research UK (RP39/2013); National Institute for Health and Care Research (ICA-CDRF-2016-02-057); National Institute for Health and Care Research (CDF-2016-09-038)
Based on 8 listed funder(s).
Publication
- Published
- 2020-12-16 · Nephrol Dial Transplant · vol. 37 · issue 2 · pp. 326–334
- Publisher
- Oxford University Press
- Cited
- 14 citations · more than 79% of similar papers · 1.2× the field average
- References
- 45 works
- Access
- Paywalled
- Research areas
- Vitamin D Research Studies · Parathyroid Disorders and Treatments · Diabetes Treatment and Management
- Keywords
- Medicine, Cholecalciferol, Regimen, Internal medicine, Kidney disease, Randomized controlled trial, Gastroenterology, Dosing, Vitamin D and neurology, Parathyroid hormone, Secondary hyperparathyroidism, Urology, Endocrinology, Calcium
- MeSH
- humans, hypercalcemia, vitamin d deficiency, cholecalciferol, parathyroid hormone, dietary supplements, child, renal insufficiency, chronic
12 authors
From IN, DE, GB
- Arpana Aprameya Iyengar · correspondingSt.John's Medical College Hospital
- Nivedita KamathSt.John's Medical College Hospital
- Hamsa V. ReddySt.John's Medical College Hospital
- Jyoti SharmaKing Edward Memorial Hospital Research Centre
- Jyoti SinghalKing Edward Memorial Hospital Research Centre
- Susan UthupGovernment Medical College
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 <30 ng/mL in 1:1:1 to oral cholecalciferol 3000 IU daily, 25 000 IU weekly or 100 000 IU monthly for 3 months (maximum three intensive courses). In those with 25OHD ≥30 ng/mL, 1000 IU cholecalciferol daily (maintenance course) was given for up to 9 months. Primary outcome was achieving 25OHD ≥30 ng/mL at the end of intensive phase treatment.
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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