Impact of two oral doses of 100,000 IU of vitamin D 3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial

• Published in: Trials Vol. 20; no. 1; p. 138
• Main Authors: Ducharme, Francine Monique, Jensen, Megan, Mailhot, Geneviève, Alos, Nathalie, White, John, Rousseau, Elizabeth, Tse, Sze Man, Khamessan, Ali, Vinet, Benjamin
• Format: Journal Article
• Language: English
• Published: England 18.02.2019
• Subjects: Pilot study; Paediatric; Viral-induced; Vitamin D; Cholecalciferol; Randomised controlled trial; Child; Asthma
• ISSN: 1745-6215
• DOI: 10.1186/s13063-019-3184-z

New evidence supports the use of supplemental vitamin D in the prevention of exacerbation of asthma; however, the optimal posology to sufficiently raise serum levels while maximising adherence is unclear. The objective was to ascertain the efficacy of high-dose vitamin D in increasing serum vitamin D in preschoolers with asthma and provide preliminary data on safety and efficacy outcomes. We conducted a 7-month, triple-blind, randomised, placebo-controlled, pilot trial of children aged 1-5 years with viral-induced asthma. Participants were allocated to receive two oral doses of 100,000 IU vitamin D (intervention) or identical placebo (control) 3.5 months apart, once in the fall and once in the winter. Serum 25-hydroxyvitamin D (25OHD) was measured by tandem mass spectrometry at baseline, 10 days, 3.5 months, 3.5 months + 10 days, and 7 months. The main outcome was the change in serum 25OHD from baseline (Δ25OHD) over time and at 3.5 and 7 months; other outcomes included the proportion of children with 25OHD ≥ 75 nmol/L, safety, and adverse event rates. Children (N = 47) were randomised (intervention, 23; control, 24) in the fall. There was a significant adjusted group difference in the Δ25OHD (95% confidence interval) of 57.8 (47.3, 68.4) nmol/L, p < 0.0001), with a time (p < 0.0001) and group*time interaction effect (p < 0.0001), in favour of the intervention. A significant group difference in the Δ25OHD was observed 10 days after the first (119.3 [105.8, 132.9] nmol/L) and second (100.1 [85.7, 114.6] nmol/L) bolus; it did not reach statistical significance at 3.5 and 7 months. At 3.5 and 7 months, respectively, 63% and 56% of the intervention group were vitamin D sufficient (≥ 75 nmol/L) compared to 39% and 36% of the control group. Hypercalciuria, all without hypercalcaemia, was observed in 8.7% of intervention and 10.3% of control samples at any time point. Exacerbations requiring rescue oral corticosteroids, which appear as a promising primary outcome, occurred at a rate of 0.87/child. Two oral boluses of 100,000 IU vitamin D once in the fall and once in the winter, rapidly, safely, and significantly raises overall serum vitamin D metabolites. However, it is sufficient to maintain 25OHD ≥ 75 nmol/L throughout 7 months in only slightly more than half of participants. ClinicalTrials.gov, NCT02197702 (23 072014). Registered on 23 July 2014.