Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000724673
Ethics application status
Approved
Date submitted
1/07/2014
Date registered
8/07/2014
Date last updated
8/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of renal specific vitamins and minerals supplementation (KVITAL) on the nutritional status and psychological wellbeing of the Haemodialysis patient: pilot study
Scientific title
Effect of renal specific vitamins and minerals supplementation (KVITAL) on the nutritional status and psychological wellbeing of the Haemodialysis patient: pilot study
Secondary ID [1] 284898 0
NIL
Universal Trial Number (UTN)
U1111-1158-6998
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 292357 0
Condition category
Condition code
Renal and Urogenital 292680 292680 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assess whether routine vitamins supplementation, using a brand of vitamins formulation that is appropriate for Chronic Kidney Disease (Kidney Vital) improves patients nutritional status and quality of life. One tablet to be taken daily, orally for 6 months
Active Ingredients and doses outlined below.
Ascorbic acid 60 mg
Biotin 30 microgram
Calcium pantothenate 5 mg
Cholecalciferol .025 mg
Copper gluconate 900 microgram
Cyanocobalamin 2.4 microgram
Ferrous fumarate 8 mg
Folic acid 400 microgram
Nicotinic acid 20 mg
Pyridoxine hydrochloride 10 mg
Riboflavin 2 mg
Sodium selenate 55 microgram
Thiamine nitrate 1.5 mg
Zinc oxide
Vitamin levels will be monitored with pathology testing, pre study and post commencement of study. Patients will be given a SF-36 Quality of life questionnaire and Subjective Global Assessment pre and post commencment of study to enstablish patient nutritional and psychological wellbeing.
Patients will be educated on the benefits of taking a daily vitamin supplement to their nutritional status and well being.
Intervention code [1] 289714 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292523 0
Vitamin and mineral defiency in haemodialysis patients may be improved with vitamin supplementation.
This outcome will be assessed by comparing pre study and post study blood pathology of vitamin and mineral levels
Timepoint [1] 292523 0
At 6 months post commencement of vitamin supplement
Primary outcome [2] 292554 0
Patients nutritional status and quality of life may be improved with implementation of a renal specific vitamin supplement to the haemodialysis patient.
This outcome will be assessed using SGA and SF-36 Quality of life questionnaire, comparing pre and post results of vitamin supplement
Timepoint [2] 292554 0
6 months post commencement of vitamin supplement
Secondary outcome [1] 309143 0
Nil
Timepoint [1] 309143 0
Nil

Eligibility
Key inclusion criteria
Chronic Kidney Disease stage 5 currently on haemodialysis at selected satellite unit
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comply to taking vitamin tablet daily for six month period of study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be educated on the benefits of taking a daily vitamin supplement. They will be advised they will be required to purchase the supplement and commit to taking the vitamin for the 6 months of the trial poject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
19/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2694 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 8395 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 289519 0
Hospital
Name [1] 289519 0
Frankston Hospital Department of Medicine - Renal
Country [1] 289519 0
Australia
Primary sponsor type
Hospital
Name
Frankston Hospital Department of Medicine- Renal
Address
Frankston Hospital
2 Hastings Rd
Frankston, Victoria, 3199
Country
Australia
Secondary sponsor category [1] 288207 0
None
Name [1] 288207 0
Address [1] 288207 0
Country [1] 288207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291264 0
Research and Ethics
Ethics committee address [1] 291264 0
Peninsula Health
PO Box 192
Mount Eliza VIC 3930
Ethics committee country [1] 291264 0
Australia
Date submitted for ethics approval [1] 291264 0
Approval date [1] 291264 0
25/06/2014
Ethics approval number [1] 291264 0
13/PH/45

Summary
Brief summary
Assess whether routine vitamins supplementation, that is appropriate for Chronic Kidney Disease (Kidney Vital) improves patients nutritional status and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49594 0
Dr Kim Wong
Address 49594 0
Nephrologist
Frankston Hospital
Department of Medicine- Renal
2 Hastings Rd,
Frankston, Victoria, 3199
Country 49594 0
Australia
Phone 49594 0
+ 61 3 9784 7777
Fax 49594 0
+61 3 9784 7289
Email 49594 0
kwong@phcn.vic.gov.au
Contact person for public queries
Name 49595 0
Julie Chimyong
Address 49595 0
Nephrology Nurse Practitioner
Frankston Hospital
Haemodialysis Unit
2 Hastings Rd
Frankston, Victoria, 3199
Country 49595 0
Australia
Phone 49595 0
+61 3 9784 8287
Fax 49595 0
+ 61 3 9784 7289
Email 49595 0
jchimyong@phcn.vic.gov.au
Contact person for scientific queries
Name 49596 0
Lee-Anne Clavarino
Address 49596 0
Peninsula Health
PO Box 192 Mount Eliza VIC 3930
Country 49596 0
Australia
Phone 49596 0
+61 3 9788 1473
Fax 49596 0
Email 49596 0
lclavarino@phcn.vic.gov.au

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
No additional documents have been identified.