Trial reportClinical pharmacokinetics2023
Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma.
Trial report in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03686150 (Vitamin D Oral Replacement in Asthma), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Vitamin D Oral Replacement in Asthma
Who cites it
6 citing papers in PubMed, 6 citations in OpenAlex.
- Pharmacokinetics Modelling Reveals Inconsistency Between the US and European Vitamin D Safety Guidelines.Biomedicines · 2026Article
- Overweight and obesity are associated with poorer treatment response and impaired pulmonary function in children with bronchial asthma: a retrospective study.American journal of translational research · 2026Article
- Vitamin D-is the sun enough for us?Nutrition & metabolism · 2025Review
- Obesity may extend the time required to reach a steady-state 25(OH)D level after initiating vitamin D supplementation.JBMR plus · 2025Article
- Pharmacokinetic modeling of prenatal vitamin D exposure and the impact on offspring asthma and pulmonary function.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2025Article
- Pediatric Asthma Control: A Focus on Vitamin D Serum Levels in Moroccan Children.Sage open pediatricsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 1 country.
Funding
Abstract
BACKGROUND AND
objectiveVitamin D insufficiency is common in several pediatric diseases including obesity and asthma. Little data exist describing the pharmacokinetics of oral vitamin D in children or the optimal dosing to achieve therapeutic 25(OH)D targets. Describe the pharmacokinetics of oral Vitamin D in children with asthma.
methodsThis was a multi-center, randomized, open-label, oral supplementation study to describe the pharmacokinetics of vitamin D in children aged 6-17 years who have asthma and were overweight/obese. Participants had a serum 25(OH)D concentration between 10 and < 30 ng/mL at baseline. In Part 1 of the study, we assessed four 16-week dosing regimens for their ability to achieve 25(OH)D concentrations ≥ 40 ng/mL. Using serial serum 25(OH)D sampling over 28 weeks, we created a population pharmacokinetic model and performed dosing simulations to achieve 25(OH)D concentrations ≥ 40 ng/mL. In Part 2, the optimal regimen chosen from Part 1 was compared (2:1) to a standard-of-care control dose (600 international units [IU] daily) over 16 weeks. A final population pharmacokinetic model using both parts was developed to perform dosing simulations and determine important co-variates in the pharmacokinetics of vitamin D.
resultsBased on empiric and simulation data, the daily dose of 8000 IU and a loading dose of 50,000 IU were chosen; this regimen raised 25(OH)D concentrations above 40 ng/mL in the majority of participants while avoiding concentrations > 100 ng/mL. A 50,000-IU loading dose led to faster achievement of 25(OH)D therapeutic concentrations (≥ 40 ng/mL). The estimated median (5th-95th percentiles) apparent clearance of vitamin D from the final population pharmacokinetic model was 0.181 (0.155-0.206) L/h. The body mass index z-score was a significant covariate on apparent clearance and was associated with a significantly decreased median half-life in 25(OH)D (body mass index z-score 1.00-1.99: 97.7 days, body mass index z-score 2.00-2.99: 65.9 days, body mass index z-score ≥ 3.00: 39.1 days, p < 0.001).
conclusionsObesity impacts vitamin D clearance and the half-life, but serum concentrations > 40 ng/mL can be reached in most children using a loading dose of 50,000 IU followed by a daily dose of 8000 IU. CLINICAL
trial registrationClinicalTrials.gov identifier number NCT03686150.
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