Trial Outcomes & Findings for Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD) (NCT NCT02805907)

Last Updated: 2017-06-16

Results Overview

Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

112 participants

Primary outcome timeframe

6 months

Results posted on

2017-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group (IG) Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Overall Study STARTED	56	56
Overall Study COMPLETED	53	53
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Group (IG) Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group (IG) n=56 Participants Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=56 Participants Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo	Total n=112 Participants Total of all reporting groups
Age, Continuous	54.57 years STANDARD_DEVIATION 15.83 • n=113 Participants	56.61 years STANDARD_DEVIATION 15.00 • n=163 Participants	55.59 years STANDARD_DEVIATION 15.39 • n=160 Participants
Sex: Female, Male Female	40 Participants n=113 Participants	47 Participants n=163 Participants	87 Participants n=160 Participants
Sex: Female, Male Male	16 Participants n=113 Participants	9 Participants n=163 Participants	25 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) White	56 Participants n=113 Participants	56 Participants n=163 Participants	112 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment Spain	56 participants n=113 Participants	56 participants n=163 Participants	112 participants n=160 Participants
Initial Asthma Control Test (ACT)	17.71 units on a scale STANDARD_DEVIATION 4.54 • n=113 Participants	19.02 units on a scale STANDARD_DEVIATION 4.59 • n=163 Participants	18.37 units on a scale STANDARD_DEVIATION 4.59 • n=160 Participants
Initial Asthma Quality of Life Questionnaire	4.38 units on a scale STANDARD_DEVIATION 1.62 • n=113 Participants	4.85 units on a scale STANDARD_DEVIATION 1.96 • n=163 Participants	4.62 units on a scale STANDARD_DEVIATION 1.91 • n=160 Participants
Asthma Severity Intermitent	5 Participants n=113 Participants	12 Participants n=163 Participants	17 Participants n=160 Participants
Asthma Severity Mild Persistent	9 Participants n=113 Participants	11 Participants n=163 Participants	20 Participants n=160 Participants
Asthma Severity Moderate Persistent	29 Participants n=113 Participants	27 Participants n=163 Participants	56 Participants n=160 Participants
Asthma Severity Severe Persistent	13 Participants n=113 Participants	6 Participants n=163 Participants	19 Participants n=160 Participants
Exacerbations	1.18 Exacerbations in the last 6 months STANDARD_DEVIATION 1.55 • n=113 Participants	1.14 Exacerbations in the last 6 months STANDARD_DEVIATION 2.70 • n=163 Participants	1.16 Exacerbations in the last 6 months STANDARD_DEVIATION 2.19 • n=160 Participants
Hospitalizations	0.11 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.31 • n=113 Participants	0.13 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.33 • n=163 Participants	0.12 Hospitalizations in the last 6 months STANDARD_DEVIATION 0.32 • n=160 Participants
Emergency care	0.45 Emergency care in the last 6 months STANDARD_DEVIATION 0.81 • n=113 Participants	0.59 Emergency care in the last 6 months STANDARD_DEVIATION 1.30 • n=163 Participants	0.52 Emergency care in the last 6 months STANDARD_DEVIATION 1.08 • n=160 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Intervention Group (IG) n=53 Participants Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=53 Participants Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Asthma Control Measured With Asthma Control Test (ACT)	20.49 units on a scale Standard Deviation 4.13	18.23 units on a scale Standard Deviation 5.70

SECONDARY outcome

Timeframe: 6 months

Number of asthma exacerbations during the study period

Outcome measures

Outcome measures
Measure	Intervention Group (IG) n=53 Participants Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=53 Participants Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Number of Asthma Exacerbations	1 Asthma exacerbations Standard Deviation 0.20	0 Asthma exacerbations Standard Deviation 0.4

SECONDARY outcome

Timeframe: 6 months

Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids: Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: \> 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),

Outcome measures

Outcome measures
Measure	Intervention Group (IG) n=53 Participants Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=53 Participants Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) Low	18 Participants	24 Participants
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) Half	30 Participants	23 Participants
Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) High	5 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months

Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.

Outcome measures

Outcome measures
Measure	Intervention Group (IG) n=53 Participants Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=53 Participants Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)	5.34 units on a scale Standard Deviation 1.29	4.64 units on a scale Standard Deviation 1.56

Adverse Events

Intervention Group (IG)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Group (CG)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention Group (IG) n=56 participants at risk Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route Calcifediol	Control Group (CG) n=56 participants at risk Placebo in a presentation with an identical appearance taken weekly by the oral route Placebo
Gastrointestinal disorders dyspepsia	5.4% 3/56 • Number of events 3 • 6 months	3.6% 2/56 • Number of events 2 • 6 months

Additional Information

Dr. Rubén Andújar-Espinosa

MurciaSalud

Phone: 0034669500052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place