Oral Intake of Mg in Controlled Asthmatic Patients

NCT06721247 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ZU-IRB#11325-3/12-2023
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the efficacy of oral magnesium supplements in controlled asthmatic patients for proper effective asthma management to reduce frequency of asthma exacerbation \& to test the effect of oral magnesium supplementation on improvement of both clinical symptoms and lung functions in patients with bronchial asthma.. The main questions it aims to answer are:

• Can oral supplementation of magnesium play a role in decrease the number of bronchial asthma exacerbations , number of ER visits , number of doctor visits and improve lung function ? Researchers will compare patients on usual treatment according to GINA guidelines 2024 group B and those taking oral magnesium together with the usual group A . Participants will:
• Take oral magnesium treatment with usual asthma medications according to GINA guidelines (2024) every day for 1year
• Visit the clinic once every 2 weeks for checkups and tests
• Keep a diary of their day and night symptoms and the number of times they had activity limitation due to asthma and the number of use reliever.

Conditions

Bronchial Asthma

Keywords

bronchial asthma

Outcome Measures

Primary Outcomes (1)

• improvement in the degree of asthma control

  By using GINA assessment of symptom control and future risk including 1) decrease daytime symptoms of asthma. 2) decrease use of relievers . 3)improvement in daily activities. 4) decrease night awakening due to asthma symptoms . By using pulmonary function tests (Spirometer) specially Forced expiratory volume in the first second (FEV1) , any improvement in pulmonary function will be measured .

  6 months to one year

Study Arms (2)

intervention group

ACTIVE COMPARATOR

oral magnesium intake is given to bronchial asthma patients together with the usual asthma medication according to GINA guidelines 2024

Drug: Magnesium; Drug: ICS+LABA

control group

PLACEBO COMPARATOR

asthmatic patients who take the usual asthma treatment according to GINA guideline 2024

Drug: ICS+LABA

Interventions

Magnesium DRUG

oral intake of magnesium for asthmatic patients with dose 200 mg per day for one year in addition to usual asthmatic treatment according to GINA guidelines 2024

intervention group

ICS+LABA DRUG

inhaled corticosteroids with long acting Beta 2 agonist are given to control group patients twice daily

control group; intervention group

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Stable controlled asthmatic patients .

You may not qualify if:

• Medical conditions and disorders (such as chronic kidney disease, diabetes mellitus, cardiac disease, alcoholism, diarrhea, and pregnancy).
• Any treatment which might affect the absorption or excretion of Mg2+ including digoxin, diuretics, and calcium-containing medications.
• Patients in asthma exacerbations .

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine Zagazig University

Zagazig, 44511, Egypt

Location

MeSH Terms

Conditions

Asthma

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of chest diseases

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: November 2, 2024
• Primary Completion: November 2, 2025
• Study Completion: November 2, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)