A randomized comparison of intramuscular high-dose versus oral maintenance vitamin D to prevent severe exacerbations in deficient/insufficient asthmatic children

Abstract

Background: A role for vitamin D supplementation in deficient/insufficient asthmatic children is controversial.

Objective: We sought to compare high-dose intramuscular (IM) + daily oral maintenance vitamin D dose versus daily oral maintenance vitamin D dose for preventing asthma exacerbations in prospectively randomized vitamin D-deficient/insufficient children aged 5 to 14 years with moderate to severe asthma.

Methods: This is an accessory post hoc analysis from a larger vitamin D supplementation trial, analyzing results of the randomized stratum of older children receiving the high dose presenting with emergency department (ED) visits for asthma and baseline blood 25-hydroxyvitamin D concentration less than or equal to 25 ng/mL. Blinded randomization to clinic-administered IM 600,000 IU every 3 months + 400 IU orally daily at home or 400 IU orally daily at home (control group) was performed. The primary outcome was need for unplanned ED asthma exacerbation visit over 0 to 12 months for moderate to severe asthma.

Results: A total of 122 children aged 5 to 14 years (61 high-dose IM 600,000 IU + Oral and 61 Oral-Only) completed a 12-month treatment. Baseline 25-hydroxyvitamin D level was less than 20 ng/mL in 84% of them. Over months 0 to 12, as the Oral-Only group was slowly repleted, the IM + Oral group remained superior to the Oral-Only group (40 [66%] with unplanned ED visits vs 50 [82%]; relative risk, 0.80 [95% CI, 0.65-1.0]; absolute risk reduction, 16% [95% CI, 1%-31%]; number needed to treat, 6.3). Over months 0 to 3, a secondary outcome, the IM 600,000 IU + Oral supplementation group had a reduction in ED visits compared with the Oral-Only group (21 [34%] vs 38 [58%]; relative risk, 0.55 [95% CI, 0.36-0.84]; absolute risk reduction, 28% [95% CI, 9%-45%]; number needed to treat, 3.4).

Conclusions: A dose of IM 600,000 IU vitamin D every 3 months significantly reduced unplanned ED visits for asthma for vitamin D-deficient/insufficient asthmatic children aged 5 to 14 years over months 0 to 12 and months 0 to 3.

Keywords: Asthma; pediatric asthma; pediatric emergency medicine; randomized trial; vitamin D; vitamin D deficiency.

Fig 1

Flow chart of patients enrolled.

Fig 2

Change in 25(OH)D blood concentration for each patient over 0 to 3 months, with (red line) or without (green line) an unplanned ED visit for asthma during that interval.