Comparison of the absorption of magnesium citrate and magnesium oxide in healthy subjects.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001268538
• Date of registration: 19/11/2015
• Prospective Registration: No
• Primary sponsor: Verla-Pharm Arzneimittel
• 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.
• Date of first enrolment: 19/06/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001268538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Assignment: Crossover;Type of endpoint: Pharmacokinetics;
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Mr Dominik Kappeler

• Name: Mr Dominik Kappeler

Key inclusion & exclusion criteria

Inclusion criteria: Male Caucasians aged between 18 and 45 years (including) in general good physical health and normal weight with normal renal function.
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.

Age minimum: 18 Years
Age maximum: 45 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Other diet and nutrition disorders

Absorption of magnesium.;
Absorption of magnesium.

Intervention(s)

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.

Primary Outcome(s)

Amount of magnesium excreted into the urine.
[Timepoint: within 24 h after intervention.]

Secondary Outcome(s)

Magnesium concentration in serum (explorative evaluation).[Predose, 60 min, 2 h, 3 h, 4 h, 5 h, 6 h, 9 h and 24 h post dose.]

Magnesium concentration in monocytes/lymphocytes (explorative evaluation).[Timepoints: predose, 9 h and 24 h post dose.]

Magnesium concentration in erythrocytes (explorative evaluation).[Predose, 9 h and 24 h post dose]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Verla-Pharm Arzneimittel

Ethics review

Status: Approved
Approval date:
Contact:

Ethikkommission der Bayerischen Landesaerztekammer