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Trial registered on ANZCTR


Registration number
ACTRN12614000677606
Ethics application status
Approved
Date submitted
26/05/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Evening Primrose Oil Improve Pruritis (Itching) in a Dialysis Population?
Scientific title
In patients with end stage renal failure on dialysis, does evening primrose oil, compared to omega -3 fish oil and placebo improve pruritis?
Secondary ID [1] 284642 0
Nil
Universal Trial Number (UTN)
U1111-1157-1944
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritis in End Stage Renal Failure 291956 0
Free Fatty Acid Intake and levels in End Stage Renal Failure 291957 0
Condition category
Condition code
Renal and Urogenital 292307 292307 0 0
Kidney disease
Metabolic and Endocrine 292308 292308 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with end stage renal failure, undergoing dialysis (in hospital or at home), will be invited to participate. Consenting participants will complete a questionnaire about pruritis (itching). Participants will
complete the Polyunsaturated Fatty Acid Food Frequency Questionnaire with an Investigator in a face to face interview. Participants will also complete a 3day
dietary recall and Patient Generated Subjective Global Assessment (PGSGA) during the interview. Blood samples will also be taken at baseline and post intervention to measure C reactive protein and red blood cell fatty acid status.
Also a doubleblinded, randomised placebo controlled
trial will be conducted where each participant will be
assigned to receive one of three capsule types:
* evening primrose oil (omega 6 fatty acids)
*fish oil (omega 3 fatty acids)
*placebo (vegetable oil)
Patients will be randomised to receive 1 of 3 interventions:
1. Active- Evening Primrose Oil, 1gram three times a day, each capsule contains 100mg of gamma-Linolenic acid
2. Active - Omega -3 Fish oil,1 gram three times a day - each capsule contains 53mg EPA and 250mg DHA, with total omega-3 = 348mg
The patients will be asked to take three capsules each day for 4 months.
Adherence will be monitored by capsule count at the end of the study as well as monitoring of the red cell fatty acid levels. Efficacy of the active groups will be assessed by response to itching, inflammatory markers .
Intervention code [1] 289427 0
Treatment: Drugs
Comparator / control treatment
Placebo- Vegetable oil,1 gram three times a day, each capsule contains 790mg oleic acid (monounsaturated oil) and 110mg linoleic acid (omega-6 fatty acid)
The duration of the study is 4 months,and 3 capsules will be required to be taken daily in each arm of the study.
Efficacy of the active groups will be assessed by response to itching and inflammatory markers . Adherence will be monitored by capsule count at the end of the studyand levels of red blood cell free fatty acids.
Control group
Placebo

Outcomes
Primary outcome [1] 292175 0
Does Evening Primrose Oil supplementation in End stage renal failure patients improve pruritis compared with omega 3?
Itch will be assessed using three methods- the visual analogue scale, rule of nines and questions involving quality of life. These are questions used specifically for itching and this is not a validated questionnaire.
The first 2 methods are both validated in assessment of itch.
Timepoint [1] 292175 0
this will be assessed at 4 months
Secondary outcome [1] 308361 0
Determine the red blood cell omega 3 status of patients with end stage renal failure.
Samples will be analysed by flame-ionisation gas chromatography (model GC-17A, Shimadzu) using a 50m x 0.25mm internal diameter capillary column. One microlitre of the sample was auto-injected into the column, and individual fatty acids were quantified using the Shimadzu analysis software . Fatty acid peaks are identified by comparison with known fatty acid standards and quantitated by comparison to the internal standard (Nu-chek and Sigma).
Timepoint [1] 308361 0
4 months
Secondary outcome [2] 308768 0
Examine whether or not there is an association between omega 3 status and pruritis.
This will be a statistical analysis.
Timepoint [2] 308768 0
4 months
Secondary outcome [3] 308769 0
Assess the effect of omega 3 supplementation (using fish oil) on markers of inflammation (C reactive
protein) using a serum assay, standardised in hospital laboratory.
Timepoint [3] 308769 0
4 months
Secondary outcome [4] 308770 0
Examine the diet quality of a cohort of end stage renal failure patients, particularly intake of polyunsaturated fatty
acids.

Using the Polyunsaturated
Fatty Acid Food Frequency Questionnaire.
Timepoint [4] 308770 0
4 months
Secondary outcome [5] 308771 0
Validate the Polyunsaturated Fatty Acid Food Frequency Questionnaire in an end stage renal failure population.
Timepoint [5] 308771 0
4 months
Secondary outcome [6] 308772 0
Compare the dietary intake of end stage renal failure patients to current evidence based practice, renal dietary guidelines, assessed via 3 day
dietary recall and via Patient Generated
Subjective Global Assessment.
Timepoint [6] 308772 0
4 months

Eligibility
Key inclusion criteria
Patients on dialysis for 3 months or more
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 2487 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 2488 0
Shellharbour Hospital - Mount Warrigal
Recruitment hospital [3] 2489 0
Shoalhaven Hospital - Nowra

Funding & Sponsors
Funding source category [1] 289266 0
Hospital
Name [1] 289266 0
Renal Unit, Wollongong Hospital
Address [1] 289266 0
Dudley Street
Wollongong
NSW 2500
Country [1] 289266 0
Australia
Funding source category [2] 289267 0
University
Name [2] 289267 0
University of Wollongong
School of Medicine
Address [2] 289267 0
Northfields Ave
Wollongong
NSW
2522
Country [2] 289267 0
Australia
Primary sponsor type
Hospital
Name
Department of Renal Medicine, WOLLONGONG hOSPITAL
Address
Dudley Street
Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 287940 0
University
Name [1] 287940 0
University of Wollongong
Faculty of Medicine
Address [1] 287940 0
Nothfields AVENUE
Wollongong
NSW 2522
Country [1] 287940 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291038 0
Human Research Ethics Committee
Ethics committee address [1] 291038 0
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Ethics committee country [1] 291038 0
Australia
Date submitted for ethics approval [1] 291038 0
Approval date [1] 291038 0
20/05/2014
Ethics approval number [1] 291038 0
HE14/051

Summary
Brief summary
Pruritis is a common symptom in patients on dialysis and has significant impact on their quality of life.
The pathophysiology is not well understood and treatments are not very effective.
Evening Primrose Oil has been used successfully in eczema and small studies suggest it may be of benefit in uraemic pruritis.This study is designed to investigate whether in fact Evening Primrose oil does has a beneficial effect on pruritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48586 0
Dr Jane Holt
Address 48586 0
Department of Renal Medicine
Wollongong Hospital
Dudley Street
Wollongong
nsw 2500
Country 48586 0
Australia
Phone 48586 0
+ 61 02 4222 5443
Fax 48586 0
Email 48586 0
jane.holt@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 48587 0
Dr Jane Holt
Address 48587 0
Department of Renal Medicine
Wollongong Hospital
Dudley Street
Wollongong
NSW 2500
Country 48587 0
Australia
Phone 48587 0
+ 61 02 4222 5443
Fax 48587 0
Email 48587 0
jane.holt@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 48588 0
A/Prof Barbara Meyer
Address 48588 0
School of Medicine
University of Wollongong
Northfields Avenue
Wollongong
NSW 2522
Country 48588 0
Australia
Phone 48588 0
+61 02 4221 3459
Fax 48588 0
Email 48588 0
bmeyer@uow.edu.au

No information has been provided regarding IPD availability
Summary results
No Results