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Trial registered on ANZCTR


Registration number
ACTRN12609000720213
Ethics application status
Approved
Date submitted
31/07/2009
Date registered
21/08/2009
Date last updated
2/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study to investigate vitamin D status and its associations with dietary vitamin D intake, sunlight exposure and selected health outcomes in peritoneal dialysis and hemodialysis patients attending the Royal Brisbane and Women's Hospital renal unit.
Scientific title
A pilot study to investigate vitamin D status and its associations with dietary vitamin D intake, sunlight exposure, kidney disease, bone disease, inflammation, metabolic syndrome and quality of life in peritoneal dialysis and hemodialysis patients.
Secondary ID [1] 283671 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 243429 0
Condition category
Condition code
Renal and Urogenital 239735 239735 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Vitamin D intake from diet and supplements for the previous month assessed by questionnaire. Sunlight exposure for the previous month assessed by questionnaire. Serum vitamin D concentration (25(OH)D on the day of dialysis clinic visit (peritoneal dialysis patients) or during their usual hemodialysis sessions (hemodialysis patients).
Intervention code [1] 237055 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240486 0
Malnutrition status - assessed using Patient Generated Subjective Global Assessment
Body mass index - assessed using height & dry weight measures
Energy and micro-nutrient intake - assessed using a 4day food diary completed over 7 days (including 1 weekend day)
Timepoint [1] 240486 0
Patient generated subjective global assessment - assessed at time of clinic visit.
Body mass index - assessed at time of clinic visit.

Energy & micronutrient intake - assessed 4 days over a 7 day period following the clinic visit.
Primary outcome [2] 240487 0
Dialysis duration - assessed from medical records
Dialysis adequacy - Assessed using urea clearance, dialysis time and total body water (Kt/V)
Estimated glomerular filtration rate - Assessed using serum creatinine, age and body weight
Potassium - serum potassium concentration analysis
Urea - serum urea concentration analysis
Albumin - serum albumin concentration analysis
Phosphate - serum phosphate concentration analysis
Calcium X phosphate - serum calcium X phosphate concentration analyses
Timepoint [2] 240487 0
Dialysis duration - assessed at time of clinic visit.
Dialysis adequacy - assessed at time of clinic visit over duration of dialysis - usually 4-5 hours
estimated Glomerular Filtration Rate - assessed at time of clinic visit.
Potassium - assessed at time of clinic visit.
Urea - assessed at time of clinic visit.
Phosphate - assessed at time of clinic visit.
Calcium X phosphate - assessed at time of clinic visit.
Secondary outcome [1] 257034 0
Markers of inflammation Pentraxin 3 - blood analysis C reactive protein- blood analysis Interleukin-6 - blood analysis Interleukin-10 - blood analysis Interleukin-12 - blood analysis Tumour-necrosis factor alpha - blood analysis asssessed in peritoneal dialysis patients.
Timepoint [1] 257034 0
Pentraxin 3, C reactive protein, Interleukin-6, Interleukin-10, Interleukin-12, Tumour-necrosis factor alpha - all assessed at time of clinic visit.
Secondary outcome [2] 257035 0
Kidney disease quality of life questionnaire score (KDQOL)
Timepoint [2] 257035 0
KDQOL - assessed at time of clinic visit.
Secondary outcome [3] 257036 0
Bone status Bone morphogenic protein 7 - blood analysis Bone-specific alkaline phosphatase - blood analysis n-terminal cross-linking telopeptide of type I collagen - urine analysis Parathyroid hormone - blood analysis in peritoneal dialysis patients.
Timepoint [3] 257036 0
Bone morphogenic protein 7, Bone-specific alkaline phosphatase , n-terminal cross-linking telopeptide of type I collagen, Parathyroid hormone - all assessed at time of clinic visit for peritoneal dialysis patients.
Secondary outcome [4] 257037 0
Metabolic syndrome status
Serum lipids - blood analysis
Urinary albumin - Urine analysis
Diabetes/prediabetes status - Medical records
Blood pressure - Mercury sphygmanometer
Timepoint [4] 257037 0
Serum lipids, Urinary albumin, Diabetes/prediabetes status, Blood pressure - all assessed at time of clinic visit.

Eligibility
Key inclusion criteria
Chronic kidney disease patients on peritoneal dialysis or hemodialysis Attending the home and independent dialysis unit at the Royal Brisbane and Women's Hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women
Patients unable to communicate in English
Patient lacking the cognitive ability to participate or give informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
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)
Recruitment hospital [1] 1773 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 7593 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 237426 0
University
Name [1] 237426 0
Queensland University of Technology
Address [1] 237426 0
Victoria Park Road
Kelvin Grove
Queensland 4059
Country [1] 237426 0
Australia
Funding source category [2] 237429 0
Hospital
Name [2] 237429 0
Royal Brisbane and Women's Hospital
Address [2] 237429 0
Butterfield Street
Herston
Queensland 4029
Country [2] 237429 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove
Queensland 4059
Country
Australia
Secondary sponsor category [1] 236921 0
Hospital
Name [1] 236921 0
Royal Brisbane and Women's Hospital
Address [1] 236921 0
Butterfield Street
Herston
Queensland 4029
Country [1] 236921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239558 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 239558 0
Level 7, Block 7
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Queensland 4029
Ethics committee country [1] 239558 0
Australia
Date submitted for ethics approval [1] 239558 0
Approval date [1] 239558 0
03/09/2010
Ethics approval number [1] 239558 0
09/QRBW/161
Ethics committee name [2] 239559 0
Queensland University of Technology HUman Research Ethics Committee
Ethics committee address [2] 239559 0
88 Musk Avenue
Queensland University of Technology
Kelvin Grove
Queensland 4059
Ethics committee country [2] 239559 0
Australia
Date submitted for ethics approval [2] 239559 0
Approval date [2] 239559 0
16/07/2009
Ethics approval number [2] 239559 0
0900000699

Summary
Brief summary
The primary purpose of the study is to investigate vitamin D and health in people with chronic kidney disease who are using peritoneal dialysis or hemodialysis. As part of the study we want to find out whether people using peritoneal dialysis have low vitamin D levels in their blood and how much vitamin D they get from food and sunlight exposure. We also want to find out whether low vitamin D is related to adverse health outcomes. Study hypotheses (alternative hypotheses) 1) Low intake of vitamin D & exposure to sunlight will be associated with low blood levels of vitamin D 2) Low blood levels of vitamin D will be associated with adverse health outcomes
Trial website
Trial related presentations / publications
Martensen, Renee, Ash, Susan, Healy, Helen, Fassett, Robert, Kimlin, Michael, Cardinal, John, et al. (2012) Vitamin D intake, sun exposure and 25-hydroxy vitamin D status in Peritoneal dialysis (PD) and Haemodialysis (HD) patients. Oral Presentation. 16th International Congress of Dietetics, 5-8 September 2012, Sydney Convention & Exhibition Centre, Sydney, NSW.

Public notes

Contacts
Principal investigator
Name 29997 0
Prof Susan Ash
Address 29997 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 29997 0
Australia
Phone 29997 0
+61 07 3138 3524
Fax 29997 0
Email 29997 0
s.ash@qut.edu.au
Contact person for public queries
Name 13244 0
Dr Dr Katherine Hanna
Address 13244 0
School of Exercise and Nutrition Sciences
Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 13244 0
Australia
Phone 13244 0
+ 61 7 3138 8202
Fax 13244 0
Email 13244 0
k.hanna@qut.edu.au
Contact person for scientific queries
Name 4172 0
Dr Katherine Hanna
Address 4172 0
School of Public Health
Queensland University of Technology
Victoria Park Road
Kelvin Grove
Queensland 4059
Country 4172 0
Australia
Phone 4172 0
+61 7 3138 8202
Fax 4172 0
Email 4172 0
k.hanna@qut.edu.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