The VIDA trial: Vitamin D3 does not improve outcomes in asthma patients
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1. Supplementation of ciclesonide with Vitamin D3 in Vitamin D deficient asthma patients did not reduce the rate of asthma treatment failure when compared with placebo.Â
2. Vitamin D3 supplementation allowed for a small decrease in the dose of ciclesonide required for symptomatic control as compared with placebo.Â
Evidence Rating Level: 1 (Excellent)
Study Rundown: Low vitamin D levels have been theorized to contribute to asthma severity through a variety of mechanisms, including immunomodulation. Low vitamin D levels may exacerbate airway inflammation and decrease response to steroid therapy, a mainstay of asthma treatment.
This study examined the effect of supplementing inhaled ciclesonide with vitamin D3 on asthma outcomes in patients with vitamin D levels < 30 ng/ml and symptomatic asthma. The primary measure of time to failure of asthma treatment – defined as decline in pulmonary function, increase in B-agonist or steroid use, and ED or hospitalization for systemic corticosteroids – showed no statistical difference between the D3 and placebo groups. Secondary measures were not statistically significant between the two groups, except that the D3 group received 14.9 µg/d less in cumulative ciclesonide dosing.
This study was limited by a low rate of asthma treatment failure in the control group as well as variable vitamin D serum levels after supplementation. Thus, future studies may demonstrate statistically significant differences in treatment failure with larger sample sizes and may potentially capture long-term benefits or risks of vitamin D3 supplementation that were missed by this short study period of 28 weeks. Nevertheless, this study demonstrates no role for vitamin D supplementation in asthma patients at this time.
Click to read the study, published today in JAMA
Relevant Reading: Vitamin D and Asthma
In-Depth [randomized controlled trial]: This study was a randomized controlled trial in which participants were initiated on an inhaled ciclesonide and levabuterol regimen and were randomized to either a placebo supplementation group (n=207) or a high-dose Vitamin D3 supplementation group (n=201). Patients received 320 µg/d of ciclesonide for 12 weeks before being tapered to 160 µg/d for 8 weeks and 80 µg/d for 8 weeks. The rate of first treatment failure was not reduced in the Vitamin D3 group compared to placebo (28% vs. 29%, respectively, p=0.54) in the study period. The only statistically significant finding among the secondary outcome measures was the overall ciclesonide dose to achieve asthma control. The Vitamin D3 group received 111.3 µg/d whereas the placebo group received 126.2 µg/d – a small difference of 14.9 µg/d (p=.03).
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