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STUDY PROTOCOL
Year : 2018  |  Volume : 1  |  Issue : 2  |  Page : 67-73

Determining the optimal dose of cholecalciferol supplementation in children with chronic kidney disease (C3 Trial): Design of an open-label multicenter randomized controlled trial


1 Department of Pediatric Nephrology, St John's Medical College Hospital, Bengaluru, Karnataka, India
2 Department of Pediatric Nephrology, Government Medical College, Trivandrum, Kerala, India
3 Department of Nephrology, KEM Hospital, Pune, Maharashtra, India
4 Department of Pediatrics, Mehta Children's Hospital, Chennai, Tamil Nadu, India, India
5 Department of Pediatric Nephrology, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK

Correspondence Address:
Dr Arpana Aprameya Iyengar
Department of Pediatric Nephrology, St John's Medical College Hospital, Bengaluru . 560 034, Karnatak
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AJPN.AJPN_34_18

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Introduction: 25-hydroxyvitamin D (25OHD) deficiency is common in children with chronic kidney disease (CKD) and can affect bone mineralization and cardiovascular morbidity. It is important to treat 25OHD deficiency appropriately in a manner that ensures not only replenishing stores but also sustaining adequate 25OHD levels without causing toxicity. The present study was planned to determine the appropriate dosing regimen for oral cholecalciferol that achieves and maintains normal 25OHD levels in children with CKD stage 2–4 and to assess the effect of various dosing regimens on bone biomarkers, secondary hyperparathyroidism, and vitamin D toxicity. Methods: We present the design of an open-label, multicenter randomized controlled trial conducted across four pediatric nephrology centers in India. Children in CKD stages 2–4 with 25OHD levels <30 ng/ml will be randomized to one of three therapy regimens for oral cholecalciferol (3000 IU daily, 25,000 IU weekly, or 100,000 IU monthly) given for 3 months, allowing an equivalent cumulative cholecalciferol dose in all arms over this intensive replacement therapy phase. After 3 months, patients with 25OHD levels ≥30 ng/ml will continue on maintenance therapy, administered at 1000 IU cholecalciferol orally daily for 9 months. Outcomes include the median change in the level of 25OHD from baseline to the end of intensive phase; proportions of children in each limb that attain and maintain normal 25OHD levels after intensive replacement and maintenance treatment; the change in levels of bone biomarkers and the incidence of adverse effects with each therapy regimes. Conclusion: The study design of a multicenter randomized controlled trial in children with CKD is described. Trial Registration: Clinical Trials Registry of India; www.ctri.nic.in; CTRI/2015/11/010180.


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