Study of the Metabolism of Two Magnesium Supplements in Healthy Volunteers

This study has been completed.
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: January 10, 2014
Last verified: January 2014
  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:


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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 27, 2010
Last Updated: January 10, 2014
Health Authority: Denmark: Danish Medicines Agency

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
Anesthetics
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 22, 2014