Trial record 4 of 71 for:    vitamin D asthma

Vitamin D Deficiency and Asthma Exacerbation (AVD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caterina Bucca, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT02661191
First received: December 21, 2015
Last updated: January 18, 2016
Last verified: January 2016
  Purpose
The study aim is in two phases. First phase: to evaluate the influence of vitamin D deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease exacerbations.

Condition Intervention
Asthma
Vitamin D Deficiency
Disease Exacerbation
Drug: oral cholecalciferol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Repletion on Asthma Exacerbation

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy) [ Time Frame: one year ] [ Designated as safety issue: No ]
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on disease exacerbations during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and number of exacerbation was investigated

  • Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Number of exacerbations were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency


Secondary Outcome Measures:
  • Relationship between serum 25-OH vitamin D level and airway obstruction (evaluated by spirometry: one second forced expiratory volume, FEV1 l/sec, vital capacity (VC) and FEV1/VC%) [ Time Frame: one year ] [ Designated as safety issue: No ]
    119 consecutive asthmatic patients underwent serum vitamin D (25-OHD, ng/ml) and lung function assessment. Their medical records were retrospectively reviewed, to gain information on lung function tests (forced expiratory volume in 1 second, FEV1, and vital capacity, VC) during the 12 months preceding study entry. The relationship between baseline 25-OH vitamin D and airway obstruction (FEV1 and FEV1/VC%) was investigated

  • Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    55 asthmatic patients with 25-OH vitamin D below 20 ng/ml underwent supplementation with cholecalciferol for one year (intramuscular 100,000 IU, followed by oral 5000 IU weekly plus 400 IU daily for one year). Lung function tests (FEV1, VC and FEV1/VC%) were recorded during the year of supplementation and compared with the data recorded during vitamin D deficiency


Enrollment: 119
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
asthma severity and disease exacerbation
intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year
Drug: oral cholecalciferol
Inhaled corticosteroids and long-acting beta-agonists, salbutamol
Other Name: intramuscular cholecalciferol

Detailed Description:

The first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin D supplementation.

In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin D supplementation. The study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were recorded during both study phases.

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months

Exclusion Criteria:

  • Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02661191

Sponsors and Collaborators
University of Turin, Italy
Investigators
Study Chair: Caterina B Bucca, MD Dept. Medical Science, University of Turin
  More Information

Publications:
Responsible Party: Caterina Bucca, Professor of Respiratory Medicine, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02661191     History of Changes
Other Study ID Numbers: ASTHMAVITD 
Study First Received: December 21, 2015
Last Updated: January 18, 2016
Health Authority: Italy: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Turin, Italy:
asthma
vitamin D
exacerbations
airway obstruction

Additional relevant MeSH terms:
Asthma
Vitamin D Deficiency
Vitamins
Vitamin D
Ergocalciferols
Disease Progression
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Disease Attributes
Pathologic Processes
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 25, 2016