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Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study.

Publication ,  Journal Article
James, L; O'Sullivan, BP; Majure, M; Lang, J; Ounpraseuth, S; Hornik, C; Baldner, J; Garza, M; Prior, F; Lee, JY; Snowden, J
Published in: Contemp Clin Trials
September 2022

Obesity and asthma are epidemic in the United States and obesity is an independent risk factor for asthma. Low vitamin D levels (i.e. serum 25-hydroxyvitamin D) have been reported in patients with reduced lung function, more frequent respiratory infections, and asthma exacerbations. Experts have proposed that serum levels > 40 ng/mL are required to offer the immunomodulatory benefits of vitamin D. Low vitamin D levels are common in both obesity and asthma, but it is not known whether supplementation with vitamin D improves asthma symptoms. Guidance for drug development stresses the importance of early phase studies to establish accurate population pharmacokinetics (PK) and drug dosing prior to larger phase 3 trials. The PK of this fat-soluble vitamin in children with increased adiposity are unknown; as are the doses need to reach proposed immunomodulatory levels. The objective of this study is to characterize the PK of vitamin D in children with obesity. Children ages 6--18 years who had physician diagnosed asthma and a body mass index (BMI) >85th percentile will be randomized to receive either standard daily dosing or loading doses followed by standard daily dosing. Blood samples will be obtained to characterize the PK of vitamin D. The results of this study will be used to identify a sufficient dose of vitamin D supplement to raise serum levels above a pre-specified value that may result in anti-inflammatory actions that could improve asthma symptoms.

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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2022

Volume

120

Start / End Page

106861

Location

United States

Related Subject Headings

  • Vitamins
  • Vitamin D Deficiency
  • Vitamin D
  • United States
  • Randomized Controlled Trials as Topic
  • Public Health
  • Obesity
  • Humans
  • General Clinical Medicine
  • Child
 

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James, L., O’Sullivan, B. P., Majure, M., Lang, J., Ounpraseuth, S., Hornik, C., … Snowden, J. (2022). Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study. Contemp Clin Trials, 120, 106861. https://doi.org/10.1016/j.cct.2022.106861
James, Laura, Brian P. O’Sullivan, Mark Majure, Jason Lang, Song Ounpraseuth, Christoph Hornik, Jamie Baldner, et al. “Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study.Contemp Clin Trials 120 (September 2022): 106861. https://doi.org/10.1016/j.cct.2022.106861.
James L, O’Sullivan BP, Majure M, Lang J, Ounpraseuth S, Hornik C, et al. Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study. Contemp Clin Trials. 2022 Sep;120:106861.
James, Laura, et al. “Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study.Contemp Clin Trials, vol. 120, Sept. 2022, p. 106861. Pubmed, doi:10.1016/j.cct.2022.106861.
James L, O’Sullivan BP, Majure M, Lang J, Ounpraseuth S, Hornik C, Baldner J, Garza M, Prior F, Lee JY, Snowden J. Protocol for the Vitamin D Oral Replacement in Asthma (VDORA) study. Contemp Clin Trials. 2022 Sep;120:106861.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

September 2022

Volume

120

Start / End Page

106861

Location

United States

Related Subject Headings

  • Vitamins
  • Vitamin D Deficiency
  • Vitamin D
  • United States
  • Randomized Controlled Trials as Topic
  • Public Health
  • Obesity
  • Humans
  • General Clinical Medicine
  • Child