Vitamin D Oral Replacement in Children With Obesity Related Asthma: VDORA1 Randomized Clinical Trial
Clin Pharmacol Ther 2024 Feb;115(2):231-238. doi: 10.1002/cpt.3086
Brian O'Sullivan 1, Song Ounpraseuth 2, Laura James 2, Marc Majure 3, Jason Lang 4, Zhuopei Hu 2, Alan Simon 5, Scott Bickel 6, Brian Ely 7, L E Faricy 8, Maryam Garza 2, Melody Greer 2, Daniel Hsia 9, Akilah Jefferson 2, Lisa Knight 10, Jeannette Lee 2, Deborah Liptzin 11, Mehtap Haktanir Abul 12, Tamara T Perry 2, Fred Prior 2, Christine SanGiovanni 13, Jade Tam-Williams 14, Brian Wu 15, Jessica Snowden 2; ECHO IDeA States Pediatric Clinical Trial Network
Note: 50,000 IU weekly might have been better
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.
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Overview Asthma and Vitamin D contains
- Vitamin D Life pages containing ASTHMA in title (162 as of Jan 2024)
- Asthma attacks reduced in half if Vitamin D level higher than 42 nanograms – RCT May 2014
- Started with 100,000 IU loading dose and has standard-of-care Asthma drug
- Asthma may be treated by Vitamin D if more than 40 ng for 12 months – Sept 2018
- Those with Asthma or COPD had half the response to Vitamin D – March 2020
- Those with Asthma need larger doses to get the same response.
- perhaps need gut-friendly Vitamin D
- Asthma occurrence rate reduced 3X by Vitamin D – 8 study meta-analysis - Aug 2021
- Asthma in child 2.3 X more likely if both parents asthmatic (unless add Vitamin D) – VDAART Nov 2018
- Adult-onset asthma 2X more likely if low vitamin D and not hyperallergenic – May 2018
- Children had poor lung function if mothers had low vitamin D while pregnant – Nov 2022
- 26 health factors increase the risk of COVID-19 – all are proxies for low vitamin D
- CDC list of high-risk for COVID-19 includes Asthma
- Child Asthma increased 2.1 X by antibiotics, Child milk allergy increased 4.4 X by PPI – April 2018
- Asthmatic children taking Corticosteroids had 2X more vitamin D intake, but lower levels – July 2017
- Traffic pollution increases asthma unless supplement with Vitamin D (mice) June 2018
- Childhood asthma problems eliminated for months by 600,000 IU of Vitamin D injection – June 2017
- Proof that Vitamin D Works 92 health problems prevented/treated as of Nov 2020
- Asthma has been proven to be treated by Vitamin D in at least 4 random controlled trials
- Childhood asthma still reduced 4 months after 800 IU of Vitamin D daily - RCT Feb 2016
- Respiratory Disease exacerbations (Asthma, CF, COPD) may be treated by Vitamin D – July 2019
- Women with asthma 35X more likely to be vitamin D deficient – Oct 2013
- If high vitamin D during pregnancy the child is 5X less likely to get asthma
- Asthma is treated by Vitamin D – now they are trying to understand why – Feb 2015
- Increase in vitamin D deficiency may partially explain increases in asthma and allergies – Jan 2015
- Why deficiencies in vitamin D and magnesium are linked to asthma Magnesium allows muscles to relax
- Babies 3.6X more likely to go to hospital for asthma if asthmatic mother had low vitamin D while pregnant – June 2019
- The worse the bronchial asthma, the lower the vitamin D – Jan 2017 has the following chart
click on chart to see the study