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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

Tracking Information
First Submitted Date  ICMJE June 13, 2016
First Posted Date  ICMJE June 20, 2016
Results First Submitted Date  ICMJE February 14, 2017
Results First Posted Date  ICMJE June 16, 2017
Last Update Posted Date June 16, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
Asthma Control Measured With Asthma Control Test (ACT) [ Time Frame: 6 months ]
Asthma Control Test (ACT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Number of Asthma Exacerbations [ Time Frame: 6 months ]
    Number of asthma exacerbations during the study period
  • 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),
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2016)
  • Number of Asthma Exacerbations [ Time Frame: 6 months ]
  • Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0) [ Time Frame: 6 months ]
  • Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire) [ Time Frame: 6 months ]
    Mini-AQLQ (Asthma Quality of Life Questionnaire)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Calcifediol Supplementation in Asthma Control in Asthmatic Patients With Vitamin D Deficiency (ACViD)
Official Title  ICMJE 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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma, Bronchial
Intervention  ICMJE
  • Drug: Calcifediol
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Intervention Group (IG)
    Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route
    Intervention: Drug: Calcifediol
  • Placebo Comparator: Control Group (CG)
    Placebo in a presentation with an identical appearance taken weekly by the oral route
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
112
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2016)
100
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02805907
Other Study ID Numbers  ICMJE 300681
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rubén Andújar, MurciaSalud
Study Sponsor  ICMJE MurciaSalud
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rubén Andújar Espinosa, Medicine MurciaSalud
PRS Account MurciaSalud
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP