Text Size

Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers

This study is not yet open for participant recruitment.
Verified June 2012 by University of Aarhus
Sponsor:
Collaborators:
Gunnar Kjems APS
GCP-unit at Aarhus University Hospital, Aarhus, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01113138
First received: April 27, 2010
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Pharmacokinetic Study of Mablet as Oral Supplement and Magnesium Sulfate as Infusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Clearance, half-life & absorption fraction


Estimated Enrollment: 10
Study Start Date: December 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113138

Contacts
Contact: Ronald Dahl, Professor +4589492106 ronadahl@rm.dk
Contact: Mette KB Dolberg, Cand. med. +4589492106 mettdolb@rm.dk

Locations
Denmark
Research Dept. of Respiratory Medicine, Aarhus University Hospital Not yet recruiting
Aarhus C, Denmark, 8000
Contact: Mette KB Dolberg, Cand.med.     +4589492106     mettdolb@rm.dk    
Sub-Investigator: Mette KB Dolberg, Cand.med.            
Principal Investigator: Ronald Dahl, Professor            
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
Study First Received: April 27, 2010
Last Updated: June 18, 2012
Health Authority: Denmark: Danish Medicines Agency

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

Additional relevant MeSH terms:
Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 16, 2013