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Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial.

Abstract

BACKGROUND

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 D3 in increasing serum vitamin D in preschoolers with asthma and provide preliminary data on safety and efficacy outcomes.

METHODS

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 D3 (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.

RESULTS

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.

CONCLUSION

Two oral boluses of 100,000 IU vitamin D3,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.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02197702 (23 072014). Registered on 23 July 2014.

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  • Authors+Show Affiliations

    ,

    Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada. francine.m.ducharme@umontreal.ca. Department of Pediatrics, University of Montreal, Sainte-Justine University Health Centre, 3175 Côte Ste-Catherine, Montreal, Quebec, H3T 1C5, Canada. francine.m.ducharme@umontreal.ca. Department of Social and Preventive Medicine, University of Montreal, Montreal, Quebec, Canada. francine.m.ducharme@umontreal.ca.

    ,

    Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada.

    ,

    Department of Nutrition, University of Montreal, Montreal, Quebec, Canada.

    ,

    Department of Social and Preventive Medicine, University of Montreal, Montreal, Quebec, Canada.

    ,

    Department of Physiology, McGill University, Montreal, Quebec, Canada.

    ,

    Department of Pediatrics, University of Montreal, Sainte-Justine University Health Centre, 3175 Côte Ste-Catherine, Montreal, Quebec, H3T 1C5, Canada.

    ,

    Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada. Department of Pediatrics, University of Montreal, Sainte-Justine University Health Centre, 3175 Côte Ste-Catherine, Montreal, Quebec, H3T 1C5, Canada.

    ,

    Euro-Pharm International Canada, Montreal, Quebec, Canada.

    Clinical Research and Knowledge Transfer Unit on Childhood Asthma, Research Centre, Sainte-Justine University Health Centre, Montreal, Quebec, Canada.

    Source

    Trials 20:1 2019 Feb 18 pg 138

    MeSH

    Administration, Oral
    Age Factors
    Asthma
    Biomarkers
    Child, Preschool
    Cholecalciferol
    Drug Administration Schedule
    Female
    Humans
    Infant
    Male
    Pilot Projects
    Preliminary Data
    Quebec
    Seasons
    Time Factors
    Treatment Outcome
    Vitamin D
    Vitamin D Deficiency

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    30777118

    Citation

    Ducharme, Francine Monique, et al. "Impact of Two Oral Doses of 100,000 IU of Vitamin D3 in Preschoolers With Viral-induced Asthma: a Pilot Randomised Controlled Trial." Trials, vol. 20, no. 1, 2019, p. 138.
    Ducharme FM, Jensen M, Mailhot G, et al. Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial. Trials. 2019;20(1):138.
    Ducharme, F. M., Jensen, M., Mailhot, G., Alos, N., White, J., Rousseau, E., ... Vinet, B. (2019). Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial. Trials, 20(1), p. 138. doi:10.1186/s13063-019-3184-z.
    Ducharme FM, et al. Impact of Two Oral Doses of 100,000 IU of Vitamin D3 in Preschoolers With Viral-induced Asthma: a Pilot Randomised Controlled Trial. Trials. 2019 Feb 18;20(1):138. PubMed PMID: 30777118.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial. AU - Ducharme,Francine Monique, AU - Jensen,Megan, AU - Mailhot,Geneviève, AU - Alos,Nathalie, AU - White,John, AU - Rousseau,Elizabeth, AU - Tse,Sze Man, AU - Khamessan,Ali, AU - Vinet,Benjamin, Y1 - 2019/02/18/ PY - 2018/07/04/received PY - 2019/01/07/accepted PY - 2019/2/20/entrez PY - 2019/2/20/pubmed PY - 2019/6/14/medline KW - Asthma KW - Child KW - Cholecalciferol KW - Paediatric KW - Pilot study KW - Randomised controlled trial KW - Viral-induced KW - Vitamin D SP - 138 EP - 138 JF - Trials JO - Trials VL - 20 IS - 1 N2 - BACKGROUND: 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 D3 in increasing serum vitamin D in preschoolers with asthma and provide preliminary data on safety and efficacy outcomes. METHODS: 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 D3 (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. RESULTS: 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. CONCLUSION: Two oral boluses of 100,000 IU vitamin D3,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. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02197702 (23 072014). Registered on 23 July 2014. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30777118/Impact_of_two_oral_doses_of_100000_IU_of_vitamin_D3_in_preschoolers_with_viral_induced_asthma:_a_pilot_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3184-z DB - PRIME DP - Unbound Medicine ER -