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 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Handicapped Research
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- Kidney Research UK
- Universidad u hospital
- KEM Hospital Research Centre
- Gobierno
- National Institute for Health Research (NIHR)
- Gobierno
- UK National Institute for Health Research
- Organización sin fines de lucro
- Navajbai Ratan Tata Trust
- Gobierno
- NIHR Clinical Doctoral Research Fellowship
- Subvenciones
- 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)
Según 8 financiadores declarados.
Publicación
- Publicado
- 2020-12-16 · Nephrol Dial Transplant · vol. 37 · número 2 · págs. 326–334
- Editorial
- Oxford University Press
- Citado
- 14 citas · más que el 79% de estudios similares · 1.2× el promedio de su campo
- Referencias
- 45 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Parathyroid Disorders and Treatments · Diabetes Treatment and Management
- Palabras clave
- 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 autores
- Arpana Aprameya Iyengar🇮🇳 · autor de correspondenciaSt.John's Medical College Hospital
- Nivedita Kamath🇮🇳St.John's Medical College Hospital
- Hamsa V. Reddy🇮🇳St.John's Medical College Hospital
- Jyoti Sharma🇮🇳King Edward Memorial Hospital Research Centre
- Jyoti Singhal🇮🇳King Edward Memorial Hospital Research Centre
- Susan Uthup🇮🇳Government Medical College
- Sudha Ekambaram🇮🇳Dr. Mehta's Children's Hospital
- Sumithra Selvam🇮🇳St.John's Medical College Hospital
- Anja Rahn🇩🇪University of Rostock
- Dagmar‐C. Fischer🇩🇪University of Rostock
- Mandy Wan🇬🇧Great Ormond Street Hospital for Children NHS Foundation Trust
- Rukshana C. Shroff🇬🇧Great Ormond Street Hospital for Children NHS Foundation Trust
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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