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
ACTRN12615001237572
Ethics application status
Approved
Date submitted
16/10/2015
Date registered
11/11/2015
Date last updated
11/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnesium supplementation and Deoxyribonucleic acid (DNA) oxidative damage
Scientific title
Role of magnesium in maintaining DNA integrity after oxidative challenge "in vitro" in healthy young men
Secondary ID [1] 287621 0
None
Universal Trial Number (UTN)
Trial acronym
MSDOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
DNA damage after oxidative challenge in healthy subjects with sedentary life style 296429 0
DNA damage after oxidative challenge in healthy subjects who regularly exercise
296430 0
Condition category
Condition code
Diet and Nutrition 296692 296692 0 0
Other diet and nutrition disorders
Human Genetics and Inherited Disorders 296868 296868 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementation with magnesium 28 days, oral tablets 250 mg, 2 times daily.
Text message will be sent at the time for administration and Mg tablets will be returned after intervention.
Participants will NOT undergo oxidative challenge, but participants will give blood samples so that their peripheral blood lymphocytes can be evaluated in an "in vitro" test with the hydrogen-peroxide solution.
Intervention code [1] 293013 0
Treatment: Other
Comparator / control treatment
Control age-matched subjects without intervention
Participants will NOT undergo oxidative challenge, but participants will give blood samples so that their peripheral blood lymphocytes can be evaluated in an "in vitro" test with the hydrogen-peroxide solution.
Control group
Active

Outcomes
Primary outcome [1] 296296 0
Change of peripheral blood lymphocytes ( PBL) DNA susceptibility to oxidative damage will be assessed by Alkaline Comet test, where PBL will be treated either with PBS or hydrogen-peroxide before Comet test.
Timepoint [1] 296296 0
29day
Secondary outcome [1] 318105 0
Change in the level of highly damaged DNA assessed by the Comet test
Timepoint [1] 318105 0
29day

Eligibility
Key inclusion criteria
Young man (18-25 years old) athletes or sedentary
Minimum age
18 Years
Maximum age
25 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
any inflamation, chronic illness, using supplements

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Targeted number of participants was set because of the number of members of the rugby club that we collaborate with, whose management agreed to participate in the study
For the analysis of results obtained in the study one-way and two-way ANOVA will be used

Recruitment
Recruitment status
Completed
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 outside Australia
Country [1] 7210 0
Serbia and Montenegro
State/province [1] 7210 0

Funding & Sponsors
Funding source category [1] 292180 0
University
Name [1] 292180 0
University of Belgrade
Address [1] 292180 0
Vojvode Stepe 450, 11000 Belgrade, Serbia
Country [1] 292180 0
Serbia and Montenegro
Primary sponsor type
University
Name
University of Belgrade
Address
Vojvode Stepe 450, 11000 Belgrade, Serbia
Country
Serbia and Montenegro
Secondary sponsor category [1] 290854 0
None
Name [1] 290854 0
None
Address [1] 290854 0
None
Country [1] 290854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293705 0
Ethical Commetee for Clinical Trials of the University of Belgrade, Faculty of Pharmacy
Ethics committee address [1] 293705 0
Vojvode Stepe 450
11000 Belgrade
Serbia
Ethics committee country [1] 293705 0
Serbia and Montenegro
Date submitted for ethics approval [1] 293705 0
09/01/2012
Approval date [1] 293705 0
13/02/2012
Ethics approval number [1] 293705 0
199/2

Summary
Brief summary
In the study 13 rugby players and 10 university students with sedentary life-style were involved. They were randomly assigned to intervention of supplementation with magnesium for 28 days. On the 29th day blood samples were taken and in peripheral blood lymphocytes, by using alkaline comet test, the level of DNA damage was examined.
Trial website
no website
Trial related presentations / publications
We don't have any presentations or public citations at this time.
Public notes
no notes

Contacts
Principal investigator
Name 60850 0
Prof Vesna Pesic
Address 60850 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11000 Belgrade
Country 60850 0
Serbia and Montenegro
Phone 60850 0
+381113951354
Fax 60850 0
Email 60850 0
vepesic@pharmacy.bg.ac.rs
Contact person for public queries
Name 60851 0
Prof Vesna Pesic
Address 60851 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11000 Belgrade
Country 60851 0
Serbia and Montenegro
Phone 60851 0
+381113951354
Fax 60851 0
Email 60851 0
vepesic@pharmacy.bg.ac.rs
Contact person for scientific queries
Name 60852 0
Prof Vesna Pesic
Address 60852 0
Faculty of Pharmacy, University of Belgrade, Vojvode Stepe 450, 11000 Belgrade
Country 60852 0
Serbia and Montenegro
Phone 60852 0
+381113951354
Fax 60852 0
Email 60852 0
vepesic@pharmacy.bg.ac.rs

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary