Bronchial Challenge Test of Magnesium-treated Asthmatics

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Dietary Supplement: Magnesium supplement (magnesium hydroxide/ -oxide); Dietary Supplement: Placebo

• Registration Number: NCT01118923
• Lead Sponsor: University of Aarhus

Brief Summary

The present study is part of a project titled 'Magnesium in asthma and chronic obstructive pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement will benefit patients with asthma and chronic obstructive pulmonary disease.

The aim of this part of the project is to study the effect of a daily magnesium supplement on the grade of bronchial hyperreactivity in asthmatics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Study Start: 2010-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-03
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Asthma with annual symptoms, bronchial hyperreactivity and positive metacholine-test (PD20<1000 microgram

Exclusion Criteria

• Se-Mg > 2,00 mmol/L, smoking cessation less than 1 year prior to study start, major changes in eating habits within three months prior to study start and during the study period of approx. one year, various conditions (e.g. gastrointestinal disease, kidney disease, pregnancy/lactation) that may affect the study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mablet	Magnesium supplement (magnesium hydroxide/ -oxide)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
PD20 for metacholine	Two years	Bronchial hyperreactivity is expressed by the dose of inhaled metacholine necessary to achieve a decline of 20 % in FEV1 (Bronchial challenge test).

Secondary Outcome Measures

Name	Time	Method
Impulse Oscillometry for measurement of pulmonary impedance	Two years	A characteristic feature of Impulse Oscillometry is that pulmonary impedance is not derived from the respiratory signals but from the pressure-flow relationship of artificial impulse-shaped test signals which are produced by an external generator. The advantage of artificial test signals is the incomparably higher frequency contents with a relatively high consistency as far as frequency range and amplitude are concerned, so that a thorough differentiation of pulmonary function is possible.

Trial Locations

Locations (1)

Research Dept. of Respiratory Medicine, Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark