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Trial registered on ANZCTR


Registration number
ACTRN12617000160336
Ethics application status
Approved
Date submitted
12/01/2017
Date registered
30/01/2017
Date last updated
30/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of magnesium on blood vessel function
Scientific title
Effects of a diet that includes consuming a magnesium supplement on endothelial function
Secondary ID [1] 290898 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Endothelial function 301618 0
heart disease 301808 0
Condition category
Condition code
Diet and Nutrition 301326 301326 0 0
Other diet and nutrition disorders
Cardiovascular 301491 301491 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnesium supplements will be used, 400 mg/day for men and 300 mg/day for women
Participants will be provided with supplements by a researcher at a face to face visit to the University of South Australia
Participants will be asked to take the supplements as a oral tablet each day for 7 days
There is no washout period.
Participants will be asked to return any unused supplements
Intervention code [1] 296845 0
Treatment: Other
Comparator / control treatment
Magnesium supplements compared with no supplements
Control group
Active

Outcomes
Primary outcome [1] 300728 0
Ultra sound measurement of flow mediated dilatation of the brachial artery which is an accepted measure of endothelial function
Timepoint [1] 300728 0
after 1 week on supplements and 1 week of no supplements
Secondary outcome [1] 330729 0
Magnesium concentration in urine
Timepoint [1] 330729 0
at baseline and after 1 week on supplements and 1 week on no supplements

Eligibility
Key inclusion criteria
BMI greater than or equal to 18 kg/m2 and less than or equal to 30 kg/m2
Systolic BP less than or equal to 140mmHg Diastolic BP less than or equal to 90mmHg
Without self reported cardiovascular liver or kidney disease
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BMI <18 and >30kg/m2
Systolic BP >140mmHg Diastolic BP >90mmHg
Self reported cardiovascular liver or kidney disease
Taking medications that affect endothelial function e.g. sildenafil (Viagra)

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)
Allocation conducted ny another member of the research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measures analysis of variance will be used to determine between group differences

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15042 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 295325 0
University
Name [1] 295325 0
University of South AUstralia
Address [1] 295325 0
School of Pharmacy and Medical Sciences,
University of South Australia
City East Campus
Postal address: GPO Box 2471 Adelaide SA 5000
Country [1] 295325 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Pharmacy and Medical Sciences,
University of South Australia
City East Campus
Postal address: GPO Box 2471 Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 294149 0
None
Name [1] 294149 0
Address [1] 294149 0
Country [1] 294149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296660 0
HREC University of South Australia
Ethics committee address [1] 296660 0
University of South Australia

Postal address: GPO Box 2471 Adelaide SA 5000 IPC CEA 19
Ethics committee country [1] 296660 0
Australia
Date submitted for ethics approval [1] 296660 0
19/09/2016
Approval date [1] 296660 0
12/12/2016
Ethics approval number [1] 296660 0
Ethics Protocol 0000035834

Summary
Brief summary
Heart disease is a major cause of death and disability in Australia. We have already shown that diet has a key role to play in maintaining blood vessel health. A low magnesium diet is emerging as a risk factor for heart disease and is associated with an increased risk of fatal and nonfatal ischaemic heart disease. Few studies have examined the effect of Mg on endothelial function in healthy adults. The hypothesis is that an improvement blood vessel function measured by flow mediated dilatation after a high magnesium diet achieved using dietary supplements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71670 0
A/Prof Jennifer Keogh
Address 71670 0
School of Pharmacy and Medical Sciences, University of South Australia
Office: P1-23 Playford Building City East Campus
Postal address: GPO Box 2471 Adelaide SA 5000
Country 71670 0
Australia
Phone 71670 0
+61 8 83022579
Fax 71670 0
+61 8 8302 2389
Email 71670 0
jennifer.keogh@unisa.edu.au
Contact person for public queries
Name 71671 0
A/Prof Jennifer Keogh
Address 71671 0
School of Pharmacy and Medical Sciences, University of South Australia
Office: P1-23 Playford Building City East Campus
Postal address: GPO Box 2471 Adelaide SA 5000
Country 71671 0
Australia
Phone 71671 0
+61 8 83022579
Fax 71671 0
+61 8 8302 2389
Email 71671 0
jennifer.keogh@unisa.edu.au
Contact person for scientific queries
Name 71672 0
A/Prof Jennifer Keogh
Address 71672 0
School of Pharmacy and Medical Sciences, University of South Australia
Office: P1-23 Playford Building City East Campus
Postal address: GPO Box 2471 Adelaide SA 5000
Country 71672 0
Australia
Phone 71672 0
+61 8 83022579
Fax 71672 0
+61 8 8302 2389
Email 71672 0
jennifer.keogh@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results