Chirag Thakur1, Jogender Kumar2, Prawin Kumar1, Jagdish Prasad Goyal1, Kuldeep Singh1, Atul Gupta3. 1. Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India. 2. Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India. 3. Department of Pediatric Respiratory Medicine, King's College Hospital, Institute for Women's and Children's Health, London, UK.
Abstract
OBJECTIVE: To determine the role of vitamin D supplementation as an adjunct to standard treatment in childhood asthma. STUDY DESIGN: 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 placebogroups (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. RESULTS: 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. CONCLUSION:Vitamin-D supplementation as an adjunct to standard treatment does not improve asthma control in children.
RCT Entities:
OBJECTIVE: To determine the role of vitamin D supplementation as an adjunct to standard treatment in childhood asthma. STUDY DESIGN: 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. RESULTS: 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. CONCLUSION:Vitamin-D supplementation as an adjunct to standard treatment does not improve asthma control in children.