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Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01113138
First Posted: April 29, 2010
Last Update Posted: January 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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 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 pharmacokinetics of the following two magnesium supplements:

  • Mablet (dietary supplement)
  • Magnesium Sulfate (solution for infusion)

Condition Intervention
Asthma Chronic Obstructive Pulmonary Disease Dietary Supplement: Mablet (Magnesium-supplement) Drug: Magnesium Sulfate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetic Study of Mablet as Oral Supplement and Magnesium Sulfate as Infusion

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Two years ]
    Clearance, half-life & absorption fraction


Enrollment: 10
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline
Active Comparator: Mablet Dietary Supplement: Mablet (Magnesium-supplement)
Mablet: Magnesium hydroxide/ -oxide (360 mg/tablet) 3 tablets as a single dose Produced by: Gunnar Kjems APS
Other Name: Mablet
Active Comparator: Magnesium sulfate Drug: Magnesium Sulfate
Solution for a single bolus-infusion, containing 2 grams of magnesium sulfate.
Other Name: Magnesiumsulfat 'SAD'

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers.

Exclusion Criteria:

  • Smokers,
  • Using pharmaceuticals/supplements,
  • Vegans/vegetarians,
  • Major changes in eating habits within one week prior to study start.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113138


Locations
Denmark
Research Dept. of Respiratory Medicine, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Investigators
Principal Investigator: Ronald Dahl, Professor Dept. of Respiratory Medicine, Aarhus University Hospital
  More Information

Publications:

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01113138     History of Changes
Other Study ID Numbers: 9727b
First Submitted: April 27, 2010
First Posted: April 29, 2010
Last Update Posted: January 13, 2014
Last Verified: January 2014

Keywords provided by University of Aarhus:
Clearance
Half-life
Absorption fraction
Pharmacokinetics

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents