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

Iyengar, Arpana; Kamath, Nivedita; Hamsa, V; Uthup, Susan; Sharma, Jyoti; Singhal, Jyoti; Ekambaram, Sudha; Shroff, Rukshana

doi:10.4103/ajpn.ajpn_34_18

Cited by 3 publications

(9 citation statements)

References 3 publications

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“…Data from the C3 trial were used for the population PK analysis 16,17 . Participating sites were located in India (between 8° and 18.5°N of the equator) and patients were recruited between December 2015 and September 2017.…”

Section: Methodsmentioning

confidence: 99%

“…The trial enrolled children aged 1–18 years with CKD stages 2–4 with serum 25(OH)D concentrations <30 ng/mL. Children who received vitamin D preparations (including over‐the‐counter supplements) in the preceding 3 months, patients known to have nephrocalcinosis, or those with documented poor medication adherence were excluded 16,17 . The trial was registered under the Clinical Trials Registry of India (CTRI‐REF/2015/11/010180), received approval from the Institutional Ethics Committees of all participating centres, and was conducted in accordance with the ethical principles of the Declaration of Helsinki 16,17 …”

Section: Methodsmentioning

confidence: 99%

“…Data of children whose 25(OH)D concentrations fell below 30 ng/mL on the maintenance therapy but who continued to be followed up and prescribed the same colecalciferol product as in the trial were also included in this secondary analysis. Children received colecalciferol granules (D 360 granules, Torrent Pharmaceutical Limited, India) packaged and supplied by a central pharmacy 16 …”

Section: Methodsmentioning

confidence: 99%

“…16,17 The trial was registered under the Clinical Trials Registry of India (CTRI-REF/2015/11/010180), received approval from the Institutional Ethics Committees of all participating centres, and was conducted in accordance with the ethical principles of the Declaration of Helsinki. 16,17 Children were randomised 1:1:1 to oral colecalciferol 3000 IU daily, 25 000 IU weekly or 100 000 IU monthly for 3 months (maxi- • A weigh-based dosage regimen is proposed for achieving and maintaining 25(OH)D concentrations between 30-48 ng/mL. 30 ng/mL on the maintenance therapy but who continued to be followed up and prescribed the same colecalciferol product as in the trial were also included in this secondary analysis.…”

Section: Children Who Received Vitamin D Preparations (Including Over-mentioning

confidence: 99%

“…the-counter supplements) in the preceding 3 months, patients known to have nephrocalcinosis, or those with documented poor medication adherence were excluded. 16,17 The trial was registered under the Clinical Trials Registry of India (CTRI-REF/2015/11/010180), received approval from the Institutional Ethics Committees of all participating centres, and was conducted in accordance with the ethical principles of the Declaration of Helsinki. 16,17 Children were randomised 1:1:1 to oral colecalciferol 3000 IU daily, 25 000 IU weekly or 100 000 IU monthly for 3 months (maxi- • A weigh-based dosage regimen is proposed for achieving and maintaining 25(OH)D concentrations between 30-48 ng/mL.…”

Section: Children Who Received Vitamin D Preparations (Including Over-mentioning

confidence: 99%

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Population pharmacokinetics and dose optimisation of colecalciferol in paediatric patients with chronic kidney disease

Wan

Green

Iyengar

et al. 2021

Brit J Clinical Pharma

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The prevalence of vitamin D deficiency is high in children with chronic kidney disease (CKD). However, current dosing recommendations are based on limited pharmacokinetic (PK) data. This study aimed to develop a population PK model of colecalciferol that can be used to optimise colecalciferol dosing in this population.Methods: Data from 83 children with CKD were used to develop a population PK model using a nonlinear mixed effects modelling approach. Serum creatinine and type of kidney disease (glomerular vs. nonglomerular disease) were investigated as covariates, and optimal dosing was determined based on achieving and maintaining 25-hydroxyvitamin D (25(OH)D) concentration of 30-48 ng/mL. Results:The time course of 25(OH)D concentrations was best described by a 1-compartment model with the addition of a basal concentration parameter to reflect endogenous 25(OH)D production from diet and sun exposure. Colecalciferol showed wide between-subject variability in its PK, with total body weight scaled allometrically the only covariate included in the model. Model-based simulations showed that current dosing recommendations for colecalciferol can be optimised using a weightbased dosing strategy.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Children Who Received Vitamin D Preparations (Including Over-mentioning

confidence: 99%

Section: Children Who Received Vitamin D Preparations (Including Over-mentioning

confidence: 99%

See 3 more Smart Citations

Population pharmacokinetics and dose optimisation of colecalciferol in paediatric patients with chronic kidney disease

Wan

Green

Iyengar

et al. 2021

Brit J Clinical Pharma

Self Cite

View full text Add to dashboard Cite

show abstract

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age

Huey

Acharya

Silver

et al. 2020

Cochrane Database of Systematic Reviews

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

Iyengar

Kamath

Reddy

et al. 2020

Nephrology Dialysis Transplantation

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Background and objectives 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 ≥30ng/ml in children with CKD stages 2-4. Design An open-label multicenter randomized controlled trial randomized children with 25OHD concentrations<30ng/ml in 1:1:1 to oral cholecalciferol 3,000 IU daily, 25,000 IU weekly, or 100,000 IU monthly for 3-months (maximum 3 intensive courses).In those with 25OHD ≥30ng/ml 1,000IU cholecalciferol daily (maintenance course) was given for up to 9 months. Primary outcome was achieving 25OHD≥30 ng/ml at end of intensive phase treatment. Results 90 children were randomized to daily(n = 30), weekly(n = 29) or monthly(n = 31) treatment groups. At end of intensive phase, 70/90(77.8%) achieved 25OHD ≥30ng/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 ≥30ng/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 vs 41.8 ng/ml; p = 0.007). One child had 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 to those with non-glomerular disease.

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

Cited by 3 publications

References 3 publications

Population pharmacokinetics and dose optimisation of colecalciferol in paediatric patients with chronic kidney disease

Population pharmacokinetics and dose optimisation of colecalciferol in paediatric patients with chronic kidney disease

Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age

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

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