Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Brief Summary: Introduction: There are many cross-sectional studies in children and adults indicating that low vitamin D levels in asthmatic patients are correlated with poorer asthma control, poorer lung function, decreased response to glucocorticoids and more frequent exacerbations. Moreover, as there is a significant group of asthmatic patients having insufficient control of their disease, despite high doses of inhaled corticosteroids, we have investigated new treatment alternatives, which include vitamin

Objective: To determine the efficacy of vitamin D supplementation in asthmatic patients with vitamin D deficiency in degree of asthma control.

Materials and methods: A prospective, controlled, randomised, triple-blind study was conducted with a follow-up of 6 months. The patients recruited were over 18 years of age with a medical diagnosis of bronchial asthma and serum 25(OH)D3 levels \< 30 ng/ml. Patients were excluded if they had a smoking habit ≥ 10 pack-years, taking vitamin D supplements, kidney disease (creat. \> 2 mg/dl), hypercalcaemia (corrected with proteins \> 10.5 mg/dl), a repeat episodes of renal colic, any gastrointestinal disease that might interfere with vitamin D absorption, or severe psychosocial problems, or were pregnant or breast-feeding. The randomisation process assigned patients to one of two groups: a group that received vitamin D (in the form of calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route) and another group that received placebo in a presentation with an identical appearance and the same administration regimen. Demographic, clinical, spirometry and laboratory endpoints were collected. The primary endpoint was degree of asthma control as determined by the internationally validated Asthma Control Test (ACT). The secondary endpoints were asthma exacerbations, dose of inhaled corticosteroids and quality of life as measured using the Mini-AQLQ (Asthma Quality of Life Questionnaire).


Options:
A: Arm Label: Intervention Group (IG); Type: EXPERIMENTAL; Interventions: Drug: Calcifediol | Arm Label: Control Group (CG); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Calcifediol; Assigned to Arm(s): Intervention Group (IG) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control Group (CG)
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: Vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D; Assigned to Arm(s): Vitamin D | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: vitamin D3; Type: EXPERIMENTAL; Interventions: Drug: vitamin D3 4000 IU | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: vitamin D3 4000 IU; Assigned to Arm(s): vitamin D3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo

Answer: A