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Trial registered on ANZCTR


Registration number
ACTRN12609000863235
Ethics application status
Approved
Date submitted
1/10/2009
Date registered
6/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnesium bicarbonate supplemented spring water in postmenopausal women
Scientific title
Double-blind, placebo-controlled outpatient study of the effects of specific alkaline magnesium bicarbonate solutions on biomarkers of acid/base balance, calcium metabolism and cardiovascular risk factors in postmenopausal volunteer women
Universal Trial Number (UTN)
U1111-1111-0422
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
body acid/base balance 251956 0
bone metabolism 251966 0
cardiovascular risk factors 251967 0
Condition category
Condition code
Public Health 252141 252141 0 0
Other public health
Diet and Nutrition 252156 252156 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Magnesium bicarbonate supplemented spring water: 650 mg/L bicarbonate, 120 mg/L magnesium at pH 8.3 to 8.5. Daily intake 1500-1800 mls equals 975-1170 mg bicarbonate, 180-216 mg magnesium. Subjects consumed the water for 84 days.
Intervention code [1] 241367 0
Other interventions
Intervention code [2] 241380 0
Prevention
Comparator / control treatment
The placebo was spring water with no added supplements.
Control group
Placebo

Outcomes
Primary outcome [1] 253012 0
Markers of bone turnover (parathyroid hormone, 25-dihydroxyvitamin D, osteocalcin, urinary telopeptides, hydroxyproline) measured by analyses of blood and urine
Timepoint [1] 253012 0
Measurements were made at baseline, 14, 43 and 84 days.
Primary outcome [2] 253014 0
Markers of inflammation - erythrocyte sedimentation rate and C-reactive protein (ESR, CRP) measured by analysis of blood
Timepoint [2] 253014 0
Measurements were made at baseline, 14, 43 and 84 days.
Secondary outcome [1] 257804 0
urinary pH
Timepoint [1] 257804 0
Measurements were made at baseline, 14, 43 and 84 days.
Secondary outcome [2] 257806 0
Venous blood pH
Timepoint [2] 257806 0
Measurements were made at baseline, 14, 43 and 84 days.
Secondary outcome [3] 257807 0
blood pressure measured by sphygmomanometer
Timepoint [3] 257807 0
Measurements were made at baseline, 14, 43 and 84 days.
Secondary outcome [4] 257808 0
serum lipids
Timepoint [4] 257808 0
Measurements were made at baseline, 14, 43 and 84 days.
Secondary outcome [5] 257810 0
serum biochemistry (electrolytes, calcium, magnsium, phosphate) by blood analysis
Timepoint [5] 257810 0
Measurements were made at baseline, 14, 43 and 84 days.

Eligibility
Key inclusion criteria
Heatlhy postmenopausal females, 50-70 years, body mass index (BMI) 20-35kg/m2
Minimum age
50 Years
Maximum age
70 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded if serious health issues or major laboratory abnormalities. Restrictions were placed on concomitant medications containing calcium and magnesium, diuretics and antacids. Restrictions were placed on major lifestyle modifications during the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects screened for eligibility up to 14 days prior to randomisation which was done sequentially 1:1. A third party storage facility supplied the study product to subjects' homes (bottles delivered by the case, 24 per case). All bottles were identical in appearance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation code was generated by Datapharm Australia Pty Ltd, on behalf of the Sponsor and supplied to the packaging company which was responsible for labelling and packing both the supplemented water and the placebo spring water.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243829 0
Commercial sector/Industry
Name [1] 243829 0
Unique Global Possibilities Medical Pty Ltd
Address [1] 243829 0
Holman Webb Lawyers Level 17, Angel Place 123 Pitt Street Sydney NSW 2000
Country [1] 243829 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Unique Global Possibilities Medical Pty Ltd
Address
Holman Webb Lawyers Level 17, Angel Place 123 Pitt Street Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 237176 0
Commercial sector/Industry
Name [1] 237176 0
Unique Global Possibilities, Inc.
Address [1] 237176 0
400 Capitol Mall, Suite 900
Sacramento, CA 95814
USA
Country [1] 237176 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243957 0
St Vincent's Hospital /University of New South Wales
Ethics committee address [1] 243957 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 243957 0
Australia
Date submitted for ethics approval [1] 243957 0
Approval date [1] 243957 0
11/05/2005
Ethics approval number [1] 243957 0
H05/045

Summary
Brief summary
The study aimed to compare changes in various blood and urine markers of bone metabolism and inflammation in post-menopausal women drinking magnesium bicarbonate supplemented spring water or spring water without supplements. Additionally, the following other factors were investigated for change between treatment groups and general safety
1.venous blood pH
2.urine pH
3.blood pressure
4.serum lipids
5.serum biochemistry
6.haematology
7.urinalysis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30348 0
Address 30348 0
Country 30348 0
Phone 30348 0
Fax 30348 0
Email 30348 0
Contact person for public queries
Name 13595 0
Russell Beckett
Address 13595 0
Unique Global Possibilities Medical Pty Ltd
Holman Webb Lawyers
Level 17, Angel Place
123 Pitt Street
Sydney NSW 2000
Country 13595 0
Australia
Phone 13595 0
+61 2 9390 8000
Fax 13595 0
+61 2 9390 8390
Email 13595 0
tanyashelley@yahoo.com.au
Contact person for scientific queries
Name 4523 0
Russell Beckett
Address 4523 0
Unique Global Possibilities Medical Pty Ltd
Holman Webb Lawyers
Level 17, Angel Place
123 Pitt Street
Sydney NSW 2000
Country 4523 0
Australia
Phone 4523 0
+61 2 9390 8000
Fax 4523 0
+61 2 9390 8390
Email 4523 0
tanyashelley@yahoo.com.au

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