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Trial registered on ANZCTR
Registration number
ACTRN12611001097932
Ethics application status
Approved
Date submitted
17/10/2011
Date registered
21/10/2011
Date last updated
1/02/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of lowering salt intake on ambulatory blood pressure and cardiovascular risk in patients with chronic kidney disease
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Scientific title
A double-blind placebo-controlled trial of low versus moderate sodium intake to reduce ambulatory blood pressure and cardiovascular risk in patients with moderate chronic kidney disease
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Secondary ID [1]
273206
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Nil
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Universal Trial Number (UTN)
U1111-1125-2149
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Trial acronym
LowSALT CKD Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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Cardiovascular risk factors
278988
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Condition category
Condition code
Renal and Urogenital
279148
279148
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0
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Kidney disease
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Cardiovascular
279170
279170
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0
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Hypertension
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Diet and Nutrition
279171
279171
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This will be a 2 phase study with phase 1 encompassing a randomised, controlled, double-blinded cross-over trial, and phase 2 involving long-term follow up to six months.
Trial periods:
Phase 1:
1) Run-in (washout) period: 1 week.
All participants will begin the trial consuming a low sodium diet (containing less than 60 mmol sodium per day).
2) First intervention period: 2 week.
All participants will continue on a low sodium diet but will be randomised to receive either sodium capsules (120 mmol of sodium chloride per day, resulting in a total target intake of 180 mmol per day) or placebo capsules (sodium consumed via diet only resulting in a total sodium intake of 60 mmol per day).
3) Washout period: 1 week.
Participants will continue on a low sodium diet as per 1) above
4) Second intervention period: 2 week.
Participants will crossover to the other tablets as per 2) above.
The order of the two interventions (low sodium intake; moderate sodium intake) will be randomised. Neither the participants nor the investigators will be aware of the treatment order.
Sodium restriction to 60 mmol per day will be facilitated by dietary education from the study dietitians with the aim to replace sodium-rich foods with lower sodium alternatives, and partial provision of food including pre-prepared meals, snack foods, spreads and sauces. Participants will have minimum fortnightly contact with the study dietitians (approximately 1 hour) to verify their dietary history forms and provide dietary education.
Phase 2: 20 weeks
Phase 2 will not include a control group; All phase 1 participants will continue on a low salt diet (goal < 100 mmol / day) to assess the translation of phase 1 results
into a practical setting and to examine long-term adherence to a low salt diet.
Sodium restriction to < 100 mmol per day will be facilitated by continued dietary education from the study dietitians by minimum monthly phone calls. Follow up measurements will occur at 4 months and 6 months (from baseline)
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Intervention code [1]
269542
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Prevention
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Intervention code [2]
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Lifestyle
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Comparator / control treatment
Moderate sodium intake (60 mmol dietary intake plus 120 mmol from sodium chloride capsules)
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in 24hr Ambulatory Blood Pressure (mm hg) assessed using ambulatory blood pressure monitor (TM-2430 Ambulatory Blood Pressure Monitor, A & D Medical, Australia).
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Assessment method [1]
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Timepoint [1]
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Ambulatory blood pressure will be measured at baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8). Measurements will be taken over 24 hours every 20 minutes from 6am to 10pm and every 30 minutes from 10pm to 6am.
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Secondary outcome [1]
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Arterial Stiffness assessed via carotid-femoral pulse wave velocity (PWV) and radial pulse wave analysis using the SphygmoCor CPV System (AtCor Medical, Australia).
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Assessment method [1]
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Timepoint [1]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [2]
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Markers of renal damage: 24-hr urinary protein and albumin (via 24-hr urine sample), and estimated glomerular filtration rate (via serum creatinine)
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Assessment method [2]
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Timepoint [2]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [3]
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Fluid status assessed using multi-frequency bio-impedance spectroscopy using Body Composition Monitor (Fresenius Medical Care, Germany), urine output (via 24 hour urine sample), weight and N-Terminal Pro-Brain Natriuretic Peptide (via blood sample), and thirst via Xerostomia Index.
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Assessment method [3]
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Timepoint [3]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [4]
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Markers of inflammation, such as C-RP and adipokines, via blood sample
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Assessment method [4]
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Timepoint [4]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [5]
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Stimulation of renin-angiotensin-aldosterone system measured via blood sample using routine methods
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Assessment method [5]
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Timepoint [5]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [6]
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Daytime sleepiness, as a marker of sleep apnea, measured via Epworth Sleepiness Scale
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Assessment method [6]
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Timepoint [6]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [7]
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Taste acuity, measured via acute taste-test study.
Taste identification testing will be performed in accordance with the International Standards Organisation (ISO), ISO 3972:1991-Sensory analysis- Methodology-Method of investigating sensitivity of taste (International Organisation for Standardisation, 1991). Participants will be presented with solutions which represent each of the five basic taste qualities, and will be asked to identify the taste and rate it according to intensity on a visual analogue scale
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Assessment method [7]
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Timepoint [7]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [8]
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Barriers and enablers to adherence measured via beliefs about dietary compliance scale (from (Welch, Bennett et al. 2006)) and attitudes to dietary recommendations (modified from (Brekke, Sunesson et al. 2004).
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Assessment method [8]
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Timepoint [8]
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Baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
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Secondary outcome [9]
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Dietary intake and adherence measured using multiple methods including:
- 24 hour urine samples (sodium and potassium),
- semi-quantitative dietary history forms (verified by study dietitians),
- a daily checklist where the participant records intake of study medication and high-sodium foods (to assess daily variation), and
- mid-stream urine samples (sodium and potassium)
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Assessment method [9]
294500
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Timepoint [9]
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24 hour urine and dietary histories at baseline (Visit 0), at the end of each of the two 2 week interventions (Visit 3 and 6), and at 4 months and 6 months (Visit 7 and 8).
Daily checklist and mid-stream urine samples will be collected weekly throught phase 1 (visit 1-6) and both phase 2 follow ups (Visits 7-8).
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Eligibility
Key inclusion criteria
- CKD stage 3 or 4 (GFR 15-59 ml/min/1.73m2) patients under the care of a nephrologist at the Princess Alexandra Hospital
- Aged at least 18 years
- Able to provide informed consent
- Systolic BP 130-169 mmHg
- Diastolic BP >70 mmHg.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable or unwilling to attend the PAH for visits as specified by the study protocol
- Receiving renal replacement therapy (dialysis or transplant) or likely to within the trial duration
- Salt-wasting CKD (as diagnosed by nephrologist)
- Prescribed > 1680 mg of sodium bicarbonate and not able to cease this medication for six weeks
- Pregnant or breastfeeding
- Life expectancy less than 6 months.
- Current involvement in other intervention
- Unable to comprehend study protocol
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients have been/will be recruited through the outpatient renal department at the Princess Alexandra Hospital.
Following 1 week run-in period, participants will be consecutively assigned a randomisation number, at the beginning of intervention 1 participants will be provided with the study medication labelled with their study number. Neither the participants nor the investigators will know which medication will be provided at each intervention.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was created using a computerised sequence generation in a 1:1 ratio by a statistician who is not part of the research team and sent directly to the pharmacy dispensing the medications.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/08/2011
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Actual
12/09/2011
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Date of last participant enrolment
Anticipated
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Actual
29/06/2012
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Date of last data collection
Anticipated
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Actual
22/01/2013
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Sample size
Target
40
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
15220
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
270039
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Charities/Societies/Foundations
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Name [1]
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Princess Alexandra Hospital Private Practice Trust Fund
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Address [1]
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Private Practice Unit, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country [1]
270039
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Australia
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Funding source category [2]
270040
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Charities/Societies/Foundations
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Name [2]
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Kidney Health Australia
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Address [2]
270040
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GPO Box 9993, Melbourne VIC 3001 (National Office)
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Country [2]
270040
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital
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Address
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Katrina Campbell
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Address [1]
269011
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Nutrition and Dietetics Department, Ground Floor, Building 15, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country [1]
269011
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Miss Emma Hall
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Address [1]
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Nutrition and Dietetics Department, Ground Floor, Building 15, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country [1]
252298
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
271992
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199 Ipswich Road, Woolloongabba, QLD 4102
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Ethics committee country [1]
271992
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Australia
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Date submitted for ethics approval [1]
271992
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14/04/2011
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Approval date [1]
271992
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22/07/2011
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Ethics approval number [1]
271992
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HREC/11/QPAH/235
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Ethics committee name [2]
272002
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University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
272002
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Research and Innovation Division
Cumbrae-Stewart (Building 72)
The University of Queensland
Brisbane, 4072
AUSTRALIA
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Ethics committee country [2]
272002
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Australia
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Date submitted for ethics approval [2]
272002
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26/08/2011
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Approval date [2]
272002
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14/09/2011
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Ethics approval number [2]
272002
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2011000956
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Summary
Brief summary
Cardiovascular disease (CVD) is the leading cause of mortality in the chronic kidney disease (CKD) population, and is independently associated with kidney function decline. Dietary sodium intake has been implicated in several traditional and novel risk factors driving both CVD and CKD progression. Despite evidence implicating dietary sodium in the pathogenesis of CVD in CKD, sodium intake in CKD patients remains high and evidence suggests that sodium restriction is not adequately emphasized for CKD patients. Part of the reason for this may be high-quality intervention trials of sodium restriction in CKD patients are lacking. Most evidence has been extrapolated from studies in non-CKD populations. However, as sodium handling is influenced by kidney function; it is highly likely that the CKD population is more susceptible to adverse effects of high dietary sodium. The aim of this study is to examine the effect of reducing sodium intake on blood pressure, progression of renal failure and other cardiovascular risk factors in patients with moderate CKD.
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Trial website
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Trial related presentations / publications
The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study): protocol of a randomized trial
http://www.biomedcentral.com/1471-2369/13/137
McMahon, E. J., et al. (2013). "A Randomized Trial of Dietary Sodium Restriction in CKD." J Am Soc Nephrol. http://www.ncbi.nlm.nih.gov/pubmed/24204003
Campbell, K. L., et al. (2014). "A randomized trial of sodium-restriction on kidney function, fluid volume and adipokines in CKD patients." BMC Nephrol 15: 57. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3994521/
McMahon EJ, Bauer J, Hawley CM, Isbel N, Stowasser M, Johnson DW, Hale R & Campbell KL.The effect of lowering salt intake on ambulatory blood pressure to reduce cardiovascular risk in chronic kidney disease (LowSALT CKD study). World Congress of Nephrology. Hong Kong May 31st-June 4th, 2013.
McMahon EJ, Bauer J, Hawley CM, Isbel N, Stowasser M, Johnson DW & Campbell KL. Effect on dietary sodium restriction on blood pressure, proteinuria and fluid volume in chronic kidney disease patients: results of randomised crossover trial and 6-month follow up. Australian and New Zealand Society Of Nephrology Conference 2013. Brisbane September 9th -11th, 2013.
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Public notes
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Contacts
Principal investigator
Name
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Dr Katrina Campbell
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Address
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Ipswich Road
Princess Alexandra Hospital, Brisbane
Woolloongabba QLD 4102
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Country
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Australia
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Phone
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+617 3176 7938
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Emma Hall
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Address
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Nutrition and Dietetics Department, Ground Floor, Building 15, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country
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Australia
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Phone
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+617 3176 7938
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Fax
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+617 3176 5619
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Email
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[email protected]
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Contact person for scientific queries
Name
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Miss Emma Hall
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Address
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Nutrition and Dietetics Department, Ground Floor, Building 15, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD 4102
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Country
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Australia
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Phone
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+617 3176 7938
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Fax
7442
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+617 3176 5619
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
A Randomized Trial of Dietary Sodium Restriction in CKD
2013
https://doi.org/10.1681/asn.2013030285
N.B. These documents automatically identified may not have been verified by the study sponsor.
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