Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000424808
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
16/04/2012
Date last updated
4/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Sodium excretion and dietary intake in people with coeliac disease, an observational study.
Scientific title
Sodium excretion and dietary intake in people with coeliac disease, an observational study.
Secondary ID [1] 280281 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 286239 0
Condition category
Condition code
Diet and Nutrition 286454 286454 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of the research is to determine the level of sodium excretion and the food sources in the diet of people with coeliac disease. Participants will be provided with digital kitchen scales and asked to provide a three-day weighed food record. They will also be asked to provide a 24-hour urine sample in order to measure sodium excretion. A DEXA scan of forearm, hip and lumbar spine will be taken on one occasion to measure bone density.
Intervention code [1] 284633 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286898 0
Sodium excretion measured by 24 hour urinary collection.
Timepoint [1] 286898 0
Baseline visit only.
Primary outcome [2] 286900 0
Dietary assessment measured by 3-day weighed food record.
Timepoint [2] 286900 0
Baseline visit only.
Secondary outcome [1] 296940 0
Bone Density measured by DXA Scan
Timepoint [1] 296940 0
Baseline

Eligibility
Key inclusion criteria
Men and women over the age of 18, with diagnosed coeliac disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria would include those with major metabolic illness such as kidney, liver or heart disease.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2012
Actual
1/05/2012
Date of last participant enrolment
Anticipated
Actual
10/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285050 0
University
Name [1] 285050 0
University of South Australia
Country [1] 285050 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
PO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 283914 0
None
Name [1] 283914 0
Address [1] 283914 0
Country [1] 283914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287055 0
University of South Australia
Ethics committee address [1] 287055 0
PO Box 2471
Adelaide SA 5001
Ethics committee country [1] 287055 0
Australia
Date submitted for ethics approval [1] 287055 0
Approval date [1] 287055 0
23/02/2012
Ethics approval number [1] 287055 0
27433

Summary
Brief summary
High sodium intake, as measured by urinary sodium excretion, is associated with increased bone loss (Divine, 1995). In Australia, the national target for salt intake was achieved by only 6% of men and 36% of women (Beard, 1997). A positive relationship exists between urinary sodium and urinary calcium excretion, with repeated studies showing that a high level of salt in the diet increases calcium excretion (Ilich, 2000). Other studies have recognised that people following a gluten-free diet have a lower bone mineral density, likely related to calcium malabsorption (Scott, 2000). It is not clear from the research how much sodium is ingested by those following a gluten free diet.
Trial website
Trial related presentations / publications
Turner, K. M., Clifton, P. M., & Keogh, J. B. (2015). Sodium and potassium excretion are related to bone mineral density in women with coeliac disease. Clinical Nutrition, 34(2), 265-268.
Public notes

Contacts
Principal investigator
Name 34028 0
A/Prof Jennifer Keogh
Address 34028 0
University of South Australia
School of Pharmacy and Medical Sciences
City East Campus
Adelaide SA 5000
Country 34028 0
Australia
Phone 34028 0
+61 8 8302 2579
Fax 34028 0
Email 34028 0
[email protected]
Contact person for public queries
Name 17275 0
A/Prof Dr. Jennifer Keogh
Address 17275 0
PO Box 2471
Adelaide SA 5001
Country 17275 0
Australia
Phone 17275 0
+61 8 8302 2579
Fax 17275 0
Email 17275 0
[email protected]
Contact person for scientific queries
Name 8203 0
A/Prof Dr. Jennifer Keogh
Address 8203 0
PO Box 2471
Adelaide, SA 5001
Country 8203 0
Australia
Phone 8203 0
+61 8 8302 2579
Fax 8203 0
Email 8203 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
EmbaseSodium and potassium excretion are related to bone mineral density in women with coeliac disease.2015https://dx.doi.org/10.1016/j.clnu.2014.04.001
N.B. These documents automatically identified may not have been verified by the study sponsor.