Vitamin D Deficiency and Asthma Exacerbation

NCT02661191 | Completed

• 1 other identifier: ASTHMAVITD
• Study Type: interventional
• Target: 119
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma; Vitamin D Deficiency; Disease Exacerbation

Keywords

asthma; vitamin D; exacerbations; airway obstruction

Outcome Measures

Primary Outcomes (2)

• Relationship between serum 25-hydroxide (OH) vitamin D level and asthma exacerbations (number/year= unscheduled visits for worsening symptoms, increase in therapy)

  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

  one year

• 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)

  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

  One year

Secondary Outcomes (2)

• 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%)

  one year

• Effect of vitamin D supplementation in patients with 25-OH vitamin D < 20 ng/ml on airway obstruction ( FEV1 l/sec, FEV1/VC%)

  one year

Study Arms (1)

asthma severity and disease exacerbation

OTHER

intramuscular cholecalciferol 100,000 IU, followed by oral cholecalciferol 5000 IU weekly plus 400 IU daily for one year

Drug: oral cholecalciferol

Interventions

oral cholecalciferol DRUG

Inhaled corticosteroids and long-acting beta-agonists, salbutamol

Also known as: intramuscular cholecalciferol

asthma severity and disease exacerbation

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.

Sponsors & Collaborators

• University of Turin, Italy: lead

Related Publications (2)

• Malinovschi A, Masoero M, Bellocchia M, Ciuffreda A, Solidoro P, Mattei A, Mercante L, Heffler E, Rolla G, Bucca C. Severe vitamin D deficiency is associated with frequent exacerbations and hospitalization in COPD patients. Respir Res. 2014 Dec 13;15(1):131. doi: 10.1186/s12931-014-0131-0.

  PMID: 25496239 BACKGROUND

• Masoero M, Bellocchia M, Ciuffreda A, Ricciardolo FL, Rolla G, Bucca C. Laryngeal spasm mimicking asthma and vitamin d deficiency. Allergy Asthma Immunol Res. 2014 May;6(3):267-9. doi: 10.4168/aair.2014.6.3.267. Epub 2014 Jan 14.

  PMID: 24843804 BACKGROUND

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency; Disease Progression; Airway Obstruction

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Caterina B Bucca, MD

  Dept. Medical Science, University of Turin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 22, 2016
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: January 22, 2016

Record last verified: 2016-01