Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000772741
Ethics application status
Approved
Date submitted
9/07/2013
Date registered
10/07/2013
Date last updated
27/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sodium and potassium supplementation on blood vessel function
Scientific title
Effect of sodium and potassium supplementation on blood vessel function in healthy adults
Secondary ID [1] 282804 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 289575 0
Condition category
Condition code
Cardiovascular 289906 289906 0 0
Diseases of the vasculature and circulation including the lymphatic system
Diet and Nutrition 289907 289907 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1) High potassium, high sodium meal (38mmol potassium; 65mmol sodium)
Arm 2) Low potassium, high sodium meal (3.1mmol potassium; 65mmol sodium)
Each meal is consumed within 5minutes and there is a minimum 7day washout between visits
Intervention code [1] 287487 0
Prevention
Comparator / control treatment
Arm 3) low potassium, low sodium meal (3.1mmol potassium; 5.5mmol sodium)
Control group
Active

Outcomes
Primary outcome [1] 289965 0
Edonthelial function as assessed by flow mediated dilatation
Timepoint [1] 289965 0
2hours post meal
Secondary outcome [1] 303674 0
Carotid-femoral pulse wave velocity measured using Sphygmo-CorEXCEL
Timepoint [1] 303674 0
2hours post meal
Secondary outcome [2] 303675 0
Augmentation index measured by pulse wave analysis using Sphygmo-CorEXCEL
Timepoint [2] 303675 0
2hours post meal
Secondary outcome [3] 303676 0
Blood pressure using Sphygmo-CorEXCEL
Timepoint [3] 303676 0
2hours post meal

Eligibility
Key inclusion criteria
18-70yr
BMI greather than 18kg/m2 and less than 30kg/m2
SBP <90mmHg DBP<130mmHg
weight stable for 6mo
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Use of antihypertensive medication, systemic steroids, folate supplementation or non-steroidal antiinflammatory
drugs
Metabolic disease such as liver or kidney disease
Treated hypertension
Previous clinical cardiovascular disease
Unable to comprehend protocol

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 contact researchers following advertisement, undergo telephone screening and are allocated to treatment order on arrival for first visit
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are allocated treatment order by an online random sequence number generator by a person independent of the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on power calculations from our previous study, with 80% power, p<0.05 to detect a minimum change in FMD of 1.3% absolute, 40 people were required in a cross over study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/07/2013
Actual
9/07/2013
Date of last participant enrolment
Anticipated
9/07/2014
Actual
16/05/2014
Date of last data collection
Anticipated
Actual
30/05/2014
Sample size
Target
40
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287582 0
University
Name [1] 287582 0
University of South Australia
Country [1] 287582 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
North Terrace
Adelaide,
South Australia 5000
Country
Australia
Secondary sponsor category [1] 286330 0
None
Name [1] 286330 0
Address [1] 286330 0
Country [1] 286330 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289555 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 289555 0
North Terrace
Adelaide,
South Australia 5000
Ethics committee country [1] 289555 0
Australia
Date submitted for ethics approval [1] 289555 0
10/05/2013
Approval date [1] 289555 0
27/06/2013
Ethics approval number [1] 289555 0
0000031547

Summary
Brief summary
The aim of this study is determine the effect of sodium to potassium ratio on postprandial endothelial function in healthy subjects. We speculate that a low sodium to potassium ratio improves postprandial endothelial function compared to high sodium to potassium ratio.
Trial website
Trial related presentations / publications
No citations to date
Public notes

Contacts
Principal investigator
Name 41314 0
A/Prof Jennifer Keogh
Address 41314 0
University of South Australia
City East Campus,
North Terrace,
Adelaide
South Australia 5000
Country 41314 0
Australia
Phone 41314 0
+61 8 8302 2579
Fax 41314 0
Email 41314 0
[email protected]
Contact person for public queries
Name 41315 0
A/Prof Jennifer Keogh
Address 41315 0
University of South Australia
City East Campus,
North Terrace,
Adelaide
South Australia 5000
Country 41315 0
Australia
Phone 41315 0
+61 8 8302 2579
Fax 41315 0
Email 41315 0
[email protected]
Contact person for scientific queries
Name 41316 0
A/Prof Jennifer Keogh
Address 41316 0
University of South Australia
City East Campus,
North Terrace,
Adelaide
South Australia 5000
Country 41316 0
Australia
Phone 41316 0
+61 8 8302 2579
Fax 41316 0
Email 41316 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
SourceTitleYear of PublicationDOI
EmbaseEffect of sodium and potassium supplementation on vascular and endothelial function: A randomized controlled trial.2015https://dx.doi.org/10.3945/ajcn.114.105197
N.B. These documents automatically identified may not have been verified by the study sponsor.