Vitamin D Deficiency and Asthma Exacerbation (AVD)

January 18, 2016 updated by: Caterina Bucca, University of Turin, Italy

Effect of Vitamin D Repletion on Asthma Exacerbation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • intramuscular cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: One year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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%)
Time Frame: one year
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Study Chair: Caterina B Bucca, MD, Dept. Medical Science, University of Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 21, 2015

First Submitted That Met QC Criteria

January 18, 2016

First Posted (Estimate)

January 22, 2016

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 18, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTHMAVITD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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