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Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial.

Publication ,  Journal Article
O'Sullivan, B; Ounpraseuth, S; James, L; Majure, M; Lang, J; Hu, Z; Simon, A; Bickel, S; Ely, B; Faricy, LE; Garza, M; Greer, M; Hsia, D ...
Published in: Clin Pharmacol Ther
February 2024

Children with asthma and obesity are more likely to have lower vitamin D levels, but the optimal replacement dose is unknown in this population. The objective of this study is identifying a vitamin D dose in children with obesity-related asthma that safely achieves serum vitamin D levels of ≥ 40 ng/mL. This prospective multisite randomized controlled trial recruited children/adolescents with asthma and body mass index ≥ 85% for age/sex. Part 1 (dose finding), evaluated 4 oral vitamin D regimens for 16 weeks to identify a replacement dose that achieved serum vitamin D levels ≥ 40 ng/mL. Part 2 compared the replacement dose calculated from part 1 (50,000 IU loading dose with 8,000 IU daily) to standard of care (SOC) for 16 weeks to identify the proportion of children achieving target serum 25(OH)D level. Part 1 included 48 randomized participants. Part 2 included 64 participants. In Part 1, no SOC participants achieved target serum level, but 50-72.7% of participants in cohorts A-C achieved the target serum level. In part 2, 78.6% of replacement dose participants achieved target serum level compared with none in the SOC arm. No related serious adverse events were reported. This trial confirmed a 50,000 IU loading dose plus 8,000 IU daily oral vitamin D as safe and effective in increasing serum 25(OH)D levels in children/adolescents with overweight/obesity to levels ≥ 40 ng/mL. Given the critical role of vitamin D in many conditions complicating childhood obesity, these data close a critical gap in our understanding of vitamin D dosing in children.

Duke Scholars

Published In

Clin Pharmacol Ther

DOI

EISSN

1532-6535

Publication Date

February 2024

Volume

115

Issue

2

Start / End Page

231 / 238

Location

United States

Related Subject Headings

  • Vitamins
  • Vitamin D Deficiency
  • Vitamin D
  • Prospective Studies
  • Pharmacology & Pharmacy
  • Pediatric Obesity
  • Humans
  • Dietary Supplements
  • Cholecalciferol
  • Child
 

Citation

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O’Sullivan, B., Ounpraseuth, S., James, L., Majure, M., Lang, J., Hu, Z., … ECHO IDeA States Pediatric Clinical Trial Network, . (2024). Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial. Clin Pharmacol Ther, 115(2), 231–238. https://doi.org/10.1002/cpt.3086
O’Sullivan, Brian, Song Ounpraseuth, Laura James, Marc Majure, Jason Lang, Zhuopei Hu, Alan Simon, et al. “Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial.Clin Pharmacol Ther 115, no. 2 (February 2024): 231–38. https://doi.org/10.1002/cpt.3086.
O’Sullivan B, Ounpraseuth S, James L, Majure M, Lang J, Hu Z, et al. Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial. Clin Pharmacol Ther. 2024 Feb;115(2):231–8.
O’Sullivan, Brian, et al. “Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial.Clin Pharmacol Ther, vol. 115, no. 2, Feb. 2024, pp. 231–38. Pubmed, doi:10.1002/cpt.3086.
O’Sullivan B, Ounpraseuth S, James L, Majure M, Lang J, Hu Z, Simon A, Bickel S, Ely B, Faricy LE, Garza M, Greer M, Hsia D, Jefferson A, Knight L, Lee J, Liptzin D, Haktanir Abul M, Perry TT, Prior F, SanGiovanni C, Tam-Williams J, Wu B, Snowden J, ECHO IDeA States Pediatric Clinical Trial Network. Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial. Clin Pharmacol Ther. 2024 Feb;115(2):231–238.
Journal cover image

Published In

Clin Pharmacol Ther

DOI

EISSN

1532-6535

Publication Date

February 2024

Volume

115

Issue

2

Start / End Page

231 / 238

Location

United States

Related Subject Headings

  • Vitamins
  • Vitamin D Deficiency
  • Vitamin D
  • Prospective Studies
  • Pharmacology & Pharmacy
  • Pediatric Obesity
  • Humans
  • Dietary Supplements
  • Cholecalciferol
  • Child