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

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ClinicalTrials.gov Identifier: NCT02805907
Recruitment Status : Completed
First Posted : June 20, 2016
Results First Posted : June 16, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Rubén Andújar, MurciaSalud

Study Description
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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).


Condition or disease Intervention/treatment Phase
Asthma, Bronchial Drug: Calcifediol Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Study Start Date : June 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group (IG)
Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
 Drug: Calcifediol
Placebo Comparator: Control Group (CG)
Placebo in a presentation with an identical appearance taken weekly by the oral route
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Asthma Control Measured With Asthma Control Test (ACT) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Number of Asthma Exacerbations [ Time Frame: 6 months ]
    Number of asthma exacerbations during the study period

  2. Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) [ Time Frame: 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),


  3. Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical diagnosis of bronchial asthma
  • serum 25(OH)D3 levels < 30 ng/ml.

Exclusion Criteria:

  • smoking habit ≥ 10 pack-years,
  • taking vitamin D supplements,
  • kidney disease (creat. > 2 mg/dl),
  • hypercalcaemia (corrected with proteins > 10.5 mg/dl),
  • repeat episodes of renal colic,
  • any gastrointestinal disease that might interfere with vitamin D absorption,
  • severe psychosocial problems,
  • pregnant
  • breast-feeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805907


Locations
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Spain
Servicio Murciano de Salud
Murcia, Spain, 30008
Sponsors and Collaborators
MurciaSalud
Investigators
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Principal Investigator: Rubén Andújar Espinosa, Medicine MurciaSalud
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rubén Andújar, Medical Doctor. Pulmonologist, MurciaSalud
ClinicalTrials.gov Identifier: NCT02805907    
Other Study ID Numbers: 300681
First Posted: June 20, 2016    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: June 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthma
Vitamin D Deficiency
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcifediol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents