Vitamin-D supplementation as an adjunct to standard treatment of asthma in children: A randomized controlled trial (ViDASTA Trial).

Abstract

To determine the role of vitamin D supplementation as an adjunct to standard treatment in childhood asthma. In this placebo-controlled, blinded, randomized controlled trial, we enrolled 60 children aged 6 to 11 years with moderate persistent asthma and randomly assigned them into intervention (2000 IU per day of vitamin D) and placebo groups (n = 30 each). The primary outcome was asthma control as assessed by the childhood asthma control test (C-ACT) scores at 12 weeks post-randomization. The secondary outcomes were improvement in the forced expiration in 1 s (FEV1 ), fractional exhaled nitric oxide (FeNO), asthma exacerbations, use of systemic steroids, number of emergency visits, post-intervention vitamin D levels, and adverse outcomes. We analyzed by intention to treat. There was no significant difference between the C-ACT score in the two groups (median [first-third quartile] scores were 25 [24-26] in both groups, p = 0.7). Also, there was no significant difference between the two groups in terms of the FEV1 , FeNO, number of exacerbations, emergency visits, hospital admissions, and adverse outcomes. However, the post-intervention vitamin D levels (ng/ml) were significantly higher in the intervention group (35.5 vs. 18.8; p < 0.001). As compared to the baseline, both the groups showed better asthma control at 12 weeks post-intervention, irrespective of the type of intervention. Vitamin-D supplementation as an adjunct to standard treatment does not improve asthma control in children.