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The Pharmacokinetics Difference between 10µg and 15µg Daily Vitamin D Doses
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  • Tao You,
  • Nadda Muhamad,
  • Joseph Jenner,
  • Zhonghui Huang
Tao You
Beyond Consulting Ltd.

Corresponding Author:tao.you@letsgobeyond.co.uk

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Nadda Muhamad
University of Liverpool
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Joseph Jenner
University of Liverpool
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Zhonghui Huang
Beyond Consulting Ltd.
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Abstract

Aim The reference nutrient intake for vitamin D in people aged ≥4 years is 10 μg/day (400 IU/day) in the UK, but the recommended daily allowance is 15 μg/day (600 IU/day) for people aged 1-70 years in the US. Here, we aim to compare the 25-hydroxyvitamin D3 (25(OH)D3) serum concentration profiles between the two doses. Methods With adult trial data, we constructed a physiologically based pharmacokinetics (PBPK) model of serum concentrations of vitamin D3 and 25(OH)D3 using nonlinear mixed effects (NLME) modelling. We used this model to forecast the mean, 5% and 95% percentiles for serum 25(OH)D3 concentrations. Results Our final model uses bodyweight to adjust volume of each compartment and maximum clearance of 25(OH)D. No other covariate was identified. The model accurately predicted data from trials of a broad range of dose regimens. We simulated subjects of the average UK male and female weights with baseline 25(OH)D < 25 nmol/L. Simulation suggests circulating 25(OH)D concentrations in >5% of men and women taking 10 μg/day for a year might fail to reach 50 nmol/L, while those on 15 μg/day were predicted to attain this threshold. Conclusion The two doses generate significant difference in serum 25(OH)D3 concentrations. This needs to be considered for choosing the right dose for the public health guideline.
17 Sep 2023Submitted to British Journal of Clinical Pharmacology
18 Sep 2023Submission Checks Completed
18 Sep 2023Assigned to Editor
18 Sep 2023Review(s) Completed, Editorial Evaluation Pending
25 Sep 2023Reviewer(s) Assigned
05 Nov 2023Editorial Decision: Revise Major
09 Feb 20241st Revision Received
12 Feb 2024Submission Checks Completed
12 Feb 2024Assigned to Editor
12 Feb 2024Review(s) Completed, Editorial Evaluation Pending
18 Feb 2024Reviewer(s) Assigned
17 Mar 2024Editorial Decision: Revise Minor
19 Mar 20242nd Revision Received
20 Mar 2024Review(s) Completed, Editorial Evaluation Pending
13 Apr 2024Editorial Decision: Revise Minor
15 Apr 20243rd Revision Received
17 Apr 2024Assigned to Editor
17 Apr 2024Submission Checks Completed
17 Apr 2024Review(s) Completed, Editorial Evaluation Pending
17 Apr 2024Reviewer(s) Assigned
29 May 2024Submission Checks Completed
29 May 2024Assigned to Editor
29 May 2024Review(s) Completed, Editorial Evaluation Pending
01 Jun 2024Editorial Decision: Accept