Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Vitamin D vs. Placebo in the Prevention of Viral-induced Exacerbations in Preschoolers With Asthma: a Pilot RCT
Brief Summary: Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.


Options:
A: Arm Label: Ciclesonide + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Ciclesonide | Arm Label: Ciclesonide + Vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3, Drug: Ciclesonide | Intervention Type: DRUG; Name: Vitamin D3; Assigned to Arm(s): Ciclesonide + Vitamin D | Intervention Type: DRUG; Name: Ciclesonide; Assigned to Arm(s): Ciclesonide + Vitamin D, Ciclesonide + placebo
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: daily vitamin D supplement, Other: Placebo | Arm Label: Vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D, Dietary Supplement: daily vitamin D supplement | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D; Assigned to Arm(s): Vitamin D | Intervention Type: DIETARY_SUPPLEMENT; Name: daily vitamin D supplement; Assigned to Arm(s): Placebo, Vitamin D | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: 2000 IU per day vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3 - Cholecalciferol 2000 IU | Arm Label: 400 IU per day vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin D - Cholecalciferol 400 IU | Intervention Type: DRUG; Name: Vitamin D - Cholecalciferol 400 IU; Assigned to Arm(s): 400 IU per day vitamin D | Intervention Type: DRUG; Name: Vitamin D3 - Cholecalciferol 2000 IU; Assigned to Arm(s): 2000 IU per day vitamin D
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: D-cure | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: D-cure; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2

Answer: B