The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000016336
Ethics application status
Approved
Date submitted
10/01/2008
Date registered
14/01/2008
Date last updated
15/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Ascorbate Supplementation in Kidney Failure
Scientific title
Ascorbate supplementation in Kidney failure and effect on quality of life
Secondary ID [1] 252228 0
Vitamin C supplementation in kidney failure: effect on uraemic symptoms
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Failure 2701 0
Condition category
Condition code
Renal and Urogenital 2821 2821 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral ascorbic acid 250mg three times a week for 3 months from when subject is first enrolled into the study
Intervention code [1] 2438 0
Treatment: Drugs
Comparator / control treatment
placebo, the exact formulation of the placebo is yet to be determined but will be of a simlar size and taste to the active treatment, with the same dosage schedule (orally three times a week for 3 months).
Control group
Placebo

Outcomes
Primary outcome [1] 3705 0
Kidney diseases quality of life short form symptom subscale score
Timepoint [1] 3705 0
3 months from when subject is first enrolled into the study
Primary outcome [2] 3711 0
Kidney quality of life short form cognitive subscale
Timepoint [2] 3711 0
3 months from when subject is first enrolled into the study
Secondary outcome [1] 6249 0
Haemodialysis cardiovascular instability. As determined by the need for fluid bolus, slowwing of ultrafiltration rate or "head down" positioning
Timepoint [1] 6249 0
at each dialysis episode which will usually be 3 times per week for three months from when subject is first enrolled into the study

Eligibility
Key inclusion criteria
Receiving maintenance dialysis treatment OR estimated Modification of Diet in Renal Diseases Glomerular Filtration Rate (MDRD GFR) of less than 20ml/min
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Life expectancy less than 3 months
Primary hyperoxaluria
Clinically unstable
Unable to provide informed consent
Unwilling to cease non study ascorbate containing supplements
Not fluent in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified by diabetic and dialysis status
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
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 postcode(s) [1] 543 0
2605

Funding & Sponsors
Funding source category [1] 2954 0
Hospital
Name [1] 2954 0
The Canberra Hospital Private Practice FundFunding
Address [1] 2954 0
The Canberra Hospital Private Practice Fund, The Canberra Hospital, 77 Yamba Drive, Garran, ACT 2611, Australia
Country [1] 2954 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
77 Yamba Drive
Garran
ACT 2605
Country
Australia
Secondary sponsor category [1] 2667 0
None
Name [1] 2667 0
Address [1] 2667 0
Country [1] 2667 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4895 0
ACT Health Human Ethics Research Committee
Ethics committee address [1] 4895 0
11 Moore St, Canberra City
Ethics committee country [1] 4895 0
Date submitted for ethics approval [1] 4895 0
02/05/2008
Approval date [1] 4895 0
01/07/2008
Ethics approval number [1] 4895 0
ETH.5/08.491

Summary
Brief summary
The primary aim of this study is to discover if giving patients with severe kidney failure ascorbate (vitamin C) reduces symptoms that are common to both renal failure and ascorbate deficiency. It is known that low ascorbate levels are common in patients with severe kidney failure, and that symptoms of scurvy (ascorbate deficiency) and of kidney failure (uraemic syndrome) overlap. There is however no consensus on whether ascorbate supplementation is beneficial in patients with severe kidney disease and there are concerns that supplementation may cause adverse effects. This study would significantly improve clinical care, by examining the benefits and adverse outcomes of supplementation.
Trial website
Trial related presentations / publications
Nephrology Dialysis Transplantation 2010; doi: 10.1093/ndt/gfq412
Public notes

Contacts
Principal investigator
Name 28288 0
Address 28288 0
Country 28288 0
Phone 28288 0
Fax 28288 0
Email 28288 0
Contact person for public queries
Name 11445 0
Richard Singer
Address 11445 0
The Canberra Hospital Renal Service
Level 8, Building 1
77 Yamba Drive
Garran
ACT 2605
Country 11445 0
Australia
Phone 11445 0
+61262242222
Fax 11445 0
+61262443281
Email 11445 0
richard.singer@act.gov.au
Contact person for scientific queries
Name 2373 0
Richard Singer
Address 2373 0
The Canberra Hospital Renal Service
Level 8, Building 1
77 Yamba Drive
Garran
ACT 2605
Country 2373 0
Australia
Phone 2373 0
+61262442222
Fax 2373 0
+61262443281
Email 2373 0
richard.singer@act.gov.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