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

• Published in: Clinical pharmacology and therapeutics 2024-02, Vol.115 (2), p.231-238
• Main Authors: O'Sullivan, Brian, Ounpraseuth, Song, James, Laura, Majure, Marc, Lang, Jason, Hu, Zhuopei, Simon, Alan, Bickel, Scott, Ely, Brian, Faricy, L.E., Garza, Maryam, Greer, Melody, Hsia, Daniel, Jefferson, Akilah, Knight, Lisa, Lee, Jeannette, Liptzin, Deborah, Haktanir Abul, Mehtap, Perry, Tamara T., Prior, Fred, SanGiovanni, Christine, Tam‐Williams, Jade, Wu, Brian, Snowden, Jessica
• Format: Article
• Language: English
• Subjects: Adolescent; Asthma - drug therapy; Child; Cholecalciferol - adverse effects; Dietary Supplements; Humans; Pediatric Obesity - chemically induced; Pediatric Obesity - complications; Pediatric Obesity - drug therapy; Prospective Studies; Vitamin D; Vitamin D Deficiency - diagnosis; Vitamin D Deficiency - drug therapy; Vitamins
• ISSN: 0009-9236; 1532-6535
• DOI: 10.1002/cpt.3086

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.