Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 231-238 |
| Number of pages | 8 |
| Journal | Clinical Pharmacology and Therapeutics |
| Volume | 115 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2024 |
Funding
This article is the product of work from the Environmental influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network. This network is a cooperative agreement with the National Institutes of Health (NIH). Only National Institutes of Health staff listed as authors have contributed to this article. Other than authors listed, the NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not represent the official views of the Environmental influences on Child Health Outcomes Program, the National Institutes of Health, or the Department of Health and Human Services. This work was conducted while Alan Simon was part of the Environmental influences on Child Health Outcomes Program at NIH. The views expressed do not necessarily reflect the views of NIH, CDC, or NCHS. Research reported in this publication was supported by the Office Of The Director, National Institutes of Health of the National Institutes of Health to the IDeA States Pediatric Clinical Trials Network under award number U24 OD024957 to University of Arkansas for Medical Sciences, UG1 OD024943 to University of Kansas Medical Center, UG1 OD024945 to the Arkansas Children's Research Institute, UG1 OD024950 to University of Oklahoma Health Sciences Center, UG1 OD024958 to Nemours Alfred I. duPont Hospital for Children, UG1 OD024953 to University of Nebraska Medical Center, UG1 OD024942 to the University of South Carolina at Columbia, UG1 OD024942 to University of Mississippi Medical Center, UG1 OD024954 to University of Louisville, UG1 OD024951 to Brown University, UG1 OD024959 to Pennington Biomedical Research Institute, UG1 OD024946 to Dartmouth University, UG1 OD024952 to Community Medical Center, UG1 OD024955 to the University of Vermont, UG1 OD024948 to Kapiolani/University of Hawaii and UG1 OD030016 to West Virginia University. The authors would like to thank the healthcare providers and staff of the participating clinics for their contribution to this project. Thank you to all of the site Principal Investigators, Research Coordinators, and Pharmacists who contributed to this study, including but not limited to: Tamara T. Perry, Lee Howard, Jill Hernandez (Arkansas Children's Research Institute); Aaron Chidekel, Kimberly Renner, Shidie Tang (Nemours Children's Health, DE); Brian Wu, Annette Amiotte, Jan Vita (Kapiolani Womens and Childrens, HI); Jade Tam-Williams, Marissa Beidelschies, Allison King (Children's Mercy, KS/MO); Scott Bickel, Jacqueline Boyd, Janice Sullivan (Louisville, KY); Daniel Hsia, Amy Thomassie, Claire Hazlett (Pennington Biomedical Research Center, LA); David Josey, Lacy Malloch (University of Mississippi Medical Center); Paul Smith, Sara Cox, Jennifer Faiella (Community Medical, MT); Hana Niebur, Jill Fahner, Dennis Picken (Children's Hospital, NE); Brian O'Sullivan, Mary McNally, Sam White (NH); Hengameh Raissy, Sarah Sanders, Jordan Barton (University of New Mexico HSC); Nighat Mehdi, Tiffany McCrabb, Kaci Taylor (University of Oklahoma Health Science Center); Christine San Giovanni, Mary Freeman, Melinda Lange (Medical University of South Carolina); Lisa Knight, Melissa Hanson, Christina Cox (University of South Carolina); LE Faricy, Laurie Chassereau (University of Vermont); and Brian Ely, Joseph Scattaregia, Michelle Shafer, and Roger Williams (West Virginia University). This article is the product of work from the Environmental influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network. This network is a cooperative agreement with the National Institutes of Health (NIH). Only National Institutes of Health staff listed as authors have contributed to this article. Other than authors listed, the NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The content is solely the responsibility of the authors and does not represent the official views of the Environmental influences on Child Health Outcomes Program, the National Institutes of Health, or the Department of Health and Human Services. This work was conducted while Alan Simon was part of the Environmental influences on Child Health Outcomes Program at NIH. The views expressed do not necessarily reflect the views of NIH, CDC, or NCHS. Research reported in this publication was supported by the Office Of The Director, National Institutes of Health of the National Institutes of Health to the IDeA States Pediatric Clinical Trials Network under award number U24 OD024957 to University of Arkansas for Medical Sciences, UG1 OD024943 to University of Kansas Medical Center, UG1 OD024945 to the Arkansas Children's Research Institute, UG1 OD024950 to University of Oklahoma Health Sciences Center, UG1 OD024958 to Nemours Alfred I. duPont Hospital for Children, UG1 OD024953 to University of Nebraska Medical Center, UG1 OD024942 to the University of South Carolina at Columbia, UG1 OD024942 to University of Mississippi Medical Center, UG1 OD024954 to University of Louisville, UG1 OD024951 to Brown University, UG1 OD024959 to Pennington Biomedical Research Institute, UG1 OD024946 to Dartmouth University, UG1 OD024952 to Community Medical Center, UG1 OD024955 to the University of Vermont, UG1 OD024948 to Kapiolani/University of Hawaii and UG1 OD030016 to West Virginia University.
| Funders | Funder number |
|---|---|
| Riley Hospital for Children | UG1 OD024942, UG1 OD024953 |
| UG1 OD024954 | |
| Centers for Disease Control and Prevention | |
| UG1 OD024943, U24 OD024957, UG1 OD024945 | |
| University of Louisville | UG1 OD024955, UG1 OD024946, UG1 OD024951, UG1 OD024952, UG1 OD030016, UG1 OD024948, UG1 OD024959 |
| UG1 OD024950, UG1 OD024958 |
Keywords
- Adolescent
- Child
- Humans
- Vitamin D
- Cholecalciferol/adverse effects
- Prospective Studies
- Vitamin D Deficiency/diagnosis
- Pediatric Obesity/complications
- Vitamins
- Asthma/drug therapy
- Dietary Supplements
