Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615001268538
Ethics application status
Approved
Date submitted
9/11/2015
Date registered
19/11/2015
Date last updated
15/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the absorption of magnesium citrate and magnesium oxide in healthy subjects.
Scientific title
Bioavailability of organic magnesium (magnesium citrate) versus inorganic magnesium (magnesium oxide) – A single-center, randomized, 2-supplementation, 2-period, 2-sequence, single-dose, cross-over study in healthy male subjects.
Secondary ID [1] 286858 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Absorption of magnesium. 295253 0
Condition category
Condition code
Diet and Nutrition 295498 295498 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 healthy male subjects are randomized to receive an oral single-dose of magnesium citrate (equivalent to 300 mg magnesium) or magnesium oxide (equivalent to 300 mg magnesium) in a cross-over design with a 3 day wash-out period under supervision of the investigators.
Intervention code [1] 292025 0
Treatment: Other
Comparator / control treatment
The control is magnesium oxide.
Control group
Active

Outcomes
Primary outcome [1] 295232 0
Amount of magnesium excreted into the urine.
Timepoint [1] 295232 0
Timepoint: within 24 h after intervention.
Secondary outcome [1] 315126 0
Magnesium concentration in monocytes/lymphocytes (explorative evaluation).
Timepoint [1] 315126 0
Timepoints: predose, 9 h and 24 h post dose.
Secondary outcome [2] 321827 0
Magnesium concentration in erythrocytes (explorative evaluation).
Timepoint [2] 321827 0
Predose, 9 h and 24 h post dose
Secondary outcome [3] 321828 0
Magnesium concentration in serum (explorative evaluation).
Timepoint [3] 321828 0
Predose, 60 min, 2 h, 3 h, 4 h, 5 h, 6 h, 9 h and 24 h post dose.

Eligibility
Key inclusion criteria
Male Caucasians aged between 18 and 45 years (including) in general good physical health and normal weight with normal renal function.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any illnesses or medication with influence on renal function.
More than moderate alcohol consumption or history of alcohol abuse.
Supplementation with magnesium.
Symptoms of magnesium deficiency.
Any gastrointestinal complaints.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/06/2015
Date of last participant enrolment
Anticipated
Actual
26/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 6954 0
Germany
State/province [1] 6954 0
Bavaria

Funding & Sponsors
Funding source category [1] 291412 0
Commercial sector/Industry
Name [1] 291412 0
Verla-Pharm Arzneimittel
Country [1] 291412 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Verla-Pharm Arzneimittel
Address
Hauptstrasse 98
82327 Tutzing
Country
Germany
Secondary sponsor category [1] 290088 0
None
Name [1] 290088 0
Address [1] 290088 0
Country [1] 290088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292961 0
Ethikkommission der Bayerischen Landesaerztekammer
Ethics committee address [1] 292961 0
Muehlbaurstrasse 16, 81677 München
Ethics committee country [1] 292961 0
Germany
Date submitted for ethics approval [1] 292961 0
Approval date [1] 292961 0
27/04/2015
Ethics approval number [1] 292961 0
15030

Summary
Brief summary
This is a randomized, controlled, cross-over study to investigate the absorption and pharmacokinetics of magnesium citrate compared with magnesium oxide after a single oral dose of magnesium. The primary outcome is the amount of magnesium excreted into the urine. The magnesium concentration in monocytes/lymphocytes and erythrocytes serve as secondary outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57822 0
Mr Dominik Kappeler
Address 57822 0
Inamed (contract research organization)
Robert-Koch-Allee 29, 82131 Gauting
Country 57822 0
Germany
Phone 57822 0
+49 89 893 569-28
Fax 57822 0
Email 57822 0
[email protected]
Contact person for public queries
Name 57823 0
Mr Dominik Kappeler
Address 57823 0
Inamed (contract research organization)
Robert-Koch-Allee 29, 82131 Gauting
Country 57823 0
Germany
Phone 57823 0
+49 89 893 569-28
Fax 57823 0
Email 57823 0
[email protected]
Contact person for scientific queries
Name 57824 0
Mr Dominik Kappeler
Address 57824 0
Inamed (contract research organization)
Robert-Koch-Allee 29, 82131 Gauting
Country 57824 0
Germany
Phone 57824 0
+49 89 893 569-28
Fax 57824 0
Email 57824 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.