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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082159
ACTR Number: ACTRN12607000381482
Trial Status: Registered
Date Submitted: 19/07/2007
Date Registered: 20/07/2007

Page 1

Public title: Salt, obesity, endothelial function and cardiovascular disease risk study 2007
ANZCTR registration title: A 4 week cross-over study investigating the effects of a low salt diet compared to a normal salt diet on blood pressure and vascular function.
Secondary ID:Commonwealth Scientific Industrial Research Organisation (CSIRO): ad29a 
UTN:
Trial acronym: SE

Page 2

Health condition(s) or problem(s) studied:
Obesity 
Condition category: Condition code:
Diet and nutrition Obesity 

Page 3

Description of intervention(s) / exposure: dietary intervention study with a low salt diet (50mmol per day)as the treatment. Volunteers will crossover to both treatments as randomly allocated with no washout between interventions.Participants are on either diet for 2 weeks, then immediately cross-over to the other intervention.
Intervention code:Lifestyle 
Comparator / control treatment: Normal salt diet (150mmol per day) as the control.
Control group: Active

Page 4

Primary outcome:Flow Mediated Dilatation (FMD): Using an ultrasound machine, we will assess the ability of the upper arm artery to become larger after being blocked with an external blood pressure cuff blown up to 250mm Hg for 5 minutes. 
Timepoint:Measured at 2 and 4 weeks. 
Secondary outcome:Blood Pressure 
Timepoint:Measured at baseline, 2 weeks and 4 weeks. 

Page 5

Key inclusion criteria: • 30 overweight and obese men and women (Body Mass Index 27-40kg/m2)• Systolic blood pressure between 130 and 160 mmHg will be selected. • weight stable over the previous 6 months.
Minimum Age: 20 Years
Maximum Age: 75 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: • Known metabolic disease such as liver or kidney disease, hypertension systolic Blood pressure>160 mmHg• Cardiovascular disease• Active weight loss in preceding 6 months

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Allocation was concealed when it was done by central randomisation by computer
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Random allocation using computer software clinstat
Masking / blinding: Open (masking not used)
Assignment: Crossover
Other design features (specify):
Type of endpoint(s): Efficacy

Page 7
Phase Phase 4
Anticipated or actual start date: 8/10/2007
Target sample size: 30
Recruitment status: Not yet recruiting

Page 8

Funding source:Government funding body e.g. Australian Research Council 
Name:Commonwealth Scientific Industrial Research Organisation 
Address: 
Country:Australia 
Primary sponsor: Government funding body e.g. Department of Health
Name: Commonwealth Scientific Industrial Research Organisation
Address:
Country: Australia
Secondary sponsor:Government funding body e.g. Department of Health 
Name:Commonwealth Scientific Industrial Research Organisation 
Address: 
Country:Australia 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:CSIRO Human Nutrition 
Address: 
Country:Australia 
Date of approval:10/01/2007 
HREC Number:06/32 
Countries of recruitment: 
Brief summary: The aim of the study is to find out what the effect of a low salt diet compared to a normal salt diet has on blood pressure and vascular function measured by ultra sound in overweight people who are at risk of heart disease.
Trial website:
Presentations / publication list:

Page 10

Contact person for public queries
Name: Anne McGuffin
Address: CSIRO Human Nutrition PO Box 10041 (Gate 13 Kintore Ave) Adelaide BC SA 5000
Country: Australia
Tel: +61 8 83038988
Fax: +61 8 8303 8899
Email: anne.mcguffin@csiro.au

Contact person for scientific queries
Name: Jennifer Keogh
Address: CSIRO Human Nutrition PO Box 10041 Gate 13 Kintore Ave Adelaide BC SA 5000
Country: Australia
Tel: +61 8303 8907
Fax: +61 8 8303 8899
Email: jennifer.keogh@csiro.au

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