Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.
Condition: Asthma; Vitamin D Deficiency
MeSH terms: Asthma; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces
      clinically important exacerbations of childhood asthma remains uncertain. We compared rapid
      to maintenance vitamin D repletion analyzed by baseline vitamin D level.
    

Detailed description: 
      Recently published Cochrane metaanalysis suggested that vitamin D reduces the risk of severe
      asthma exacerbations, but only 22 children contributed to that analysis from a study that
      found no difference in acute care visits or rescue steroid administration. Altogether,
      randomized trials performed in children show promise solely in meta-analyses that use varied
      clinical outcomes and analysis approaches.

      Were vitamin D supplementation beneficial for children with asthma, it might prevent moderate
      to severe asthma exacerbations entirely in some children, reduce the overall frequency of
      exacerbations in a treated group, or both. To examine these possibilities, we designed a
      randomized explanatory study comparing rapid vs maintenance vitamin D supplementation for
      children with moderate-to-severe asthma and with low baseline vitamin D levels .

      Children presenting to the ED with moderate-to-severe asthma exacerbations and vitamin D
      levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the
      latter daily) therapy or daily oral-only therapy, and were followed for 12 months.The primary
      outcome was patient-initiated unplanned visits for asthma exacerbations,examined two ways:
      cumulative proportions with an exacerbation, and average exacerbation frequency. As this was
      a nutrient study, we analyzed treatment groups by quartile of baseline vitamin D level,
      collecting repeat levels and clinical observations at 3, 6, 9,and 12 months after enrollment.

      One hundred and sixteen patients in the IM+oral cohort vs 115 in the oral-only cohort had
      similar mean (SD) baseline levels: 15.1 (5.4) vs 15.8 (5.2) ng/mL (range, 3-25 ng/mL). There
      was no difference in the primary outcome over the entire 12-month observation period.
      However, rapid IM+oral supplementation significantly reduced unplanned visits for asthma
      exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months:
      the relative exacerbation rate for the IM+oral cohort compared with the oral-only cohort at 3
      months was 0.48 (95% CI, 0.28-0.89; P ¼ .008); average exacerbation frequency per child
      analysis, relative rate 0.36 (95% CI, 0.13-0.87; P ¼ .017).

      So Rapid compared to maintenance vitamin D supplementation for children with the lowest
      levels resulted in short- but not long-term reduction in asthma exacerbations.
    

Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: allergy; clinical trial; exacerbation; pediatrics