Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001212145
Ethics application status
Approved
Date submitted
12/08/2019
Date registered
2/09/2019
Date last updated
28/01/2020
Date data sharing statement initially provided
2/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Surgery on Plasma Vitamin C Levels and Cognitive Function in Adults Undergoing Elective Hip Surgery
Scientific title
The Effects of Surgery on Plasma Vitamin C Levels and Cognitive Function in Adults Undergoing Elective Hip Surgery
Secondary ID [1] 299103 0
0038N_2016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative cognitive dysfunction 313998 0
Plasma vitamin C depletion 313999 0
Serum vitamin B12 depletion 314005 0
Condition category
Condition code
Neurological 312394 312394 0 0
Other neurological disorders
Diet and Nutrition 312395 312395 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Particiapnts will include adults aged between 65-85 yrs., who are undergoing elective hip surgery or age matched control participants on the waiting list or suffering from hip issues such as osteoarthritis. Consenting participants will have their surgery details (i.e. length and type of surgery, type of anaesthetic used, and any complications) distributed to the researcher. Participants will be required to primarily undergo a series of cognitive assessments and blood tests during each testing session. Participants will be required to fast for each testing session and attend a total of 5 study sessions:
• Visit 1: 1-2 weeks prior to surgery (Tests conducted at NIIM in Hawthorn)
• Visit 2: within 1 week after surgery (Tests conducted at the hospital)
• Visit 3: 4-6 weeks after surgery (Tests conducted at NIIM in Hawthorn)
• Visit 4: 3 months after surgery (Tests conducted at NIIM in Hawthorn)
• Visit 5: 6 months after surgery (Tests conducted at NIIM in Hawthorn)
Each visit will take approximately 2.5-3 hours. Cognitive tests will involve both paper and pen and computer tests. The paper and pen tests will include the Symbol Digits Modalities Test (SDMT), and the Hopkins verbal learning test revised (HVLT-R). The computerised cognitive assessment will be the Swinburne University Computerised Cognitive Assessment Battery (SUCCAB). A blood test will be taken to measure plasma vitamin C and serum vitamin B12 levels and cytokine levels.
Alongside the cognitve test and blood test, 5 Questionnaires which include a demographic and medical history questionnaire, a pain questionnaire, food frequency questionnaires, a sleep questionnaire, a mood questionnaire and wound healing questionnaire. A pulse wave velocity test (which tests for arterial stiffness) and blood pressure test will be conducted.
Intervention code [1] 315267 0
Early Detection / Screening
Comparator / control treatment
The control group will consist of participants on the waiting list for hip surgery or suffering from hip issues such as osteoarthritis. This control group will not be exposed to the surgery or be admitted to the hospital. The control group will have the same assessments undertaken at the same time points, without exposure to surgery. This control group will be used to control for potential confounders such as physiological condition, cognitive practice affects, mood, blood levels and pain.
Control group
Active

Outcomes
Primary outcome [1] 321029 0
Cognitive function:
-Swinburne University Computerised Cognitive Assessment Battery (SUCCAB)
-Hopkins Verbal Learning test-Revised (HVLT-R revised)
-Cognitive function: Symbol Digits Modalities Test (SDMT)
Timepoint [1] 321029 0
1-2 weeks prior to surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Primary outcome [2] 321035 0
Plasma vitamin C . This will be assessed by an external lab which will use a biochemical plasma assay to determine concentrations.
Timepoint [2] 321035 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [1] 373747 0
Serum vitamin B12. This will be assessed by an external lab which will use a biochemical serum assay to determine concentrations.
Timepoint [1] 373747 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [2] 373751 0
Tumor necrosis factor (TNF-a). This will be assessed by an external lab which will use a biochemical assay to determine concentrations.
Timepoint [2] 373751 0
1-2 weeks prior to surgery
4-6 weeks post surgery
6 months post surgery
Secondary outcome [3] 373754 0
Mood: Bond Lader Mood Questionnaire
Timepoint [3] 373754 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [4] 373755 0
Pain and self efficacy:
The Verbal Numerical Rating Scale (VNRS)
The Nicholas Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [4] 373755 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [5] 373756 0
Sleep quality:
Sleep Quality Assessment (PSQI)
Timepoint [5] 373756 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [6] 373757 0
Wound healing assessment:
The Cardiff wound impact questionnaire (CWIS)
Timepoint [6] 373757 0
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [7] 373758 0
Food frequency questionnaire:
Dietary Questionnaire for Epidemiological Studies Version 2 (DQES v2).
Modified version of the DQES v2 (focus on vitamin C and vitamin B12)
Timepoint [7] 373758 0
1-2 weeks prior to surgery
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [8] 373759 0
Cardiovascular assessment:
Pulse wave velocity (PWV)
Timepoint [8] 373759 0
within 1 week post surgery
4-6 weeks post surgery
3 months post surgery
6 months post surgery
Secondary outcome [9] 373981 0
Interleukin-1 (IL-1). This will be assessed by an external lab which will use a biochemical assay to determine concentrations.
Timepoint [9] 373981 0
1-2 weeks prior to surgery
4-6 weeks post surgery
6 months post surgery
Secondary outcome [10] 373982 0
Interleukin-1 (IL-6). This will be assessed by an external lab which will use a biochemical assay to determine concentrations.
Timepoint [10] 373982 0
1-2 weeks prior to surgery
4-6 weeks post surgery
6 months post surgery

Eligibility
Key inclusion criteria
-Adults 65-85 yrs. scheduled for elective hip replacement orthopaedic surgery or age matched control participants on the waiting list or suffering from hip issues such as osteoarthritis or pain/discomfort.
- Exposed to spinal anaesthetic and heavy sedation during surgery
-Good comprehension of written and spoken English
-Able to give informed consent
-Must not be taking antidepressants, antipsychotics, anxiolytics, illicit drugs or any cognitive enhancing drugs
- Not taking any vitamin C or vitamin B12 supplementation post-operatively for the duration of the study
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Colour blindness or any other severe visual impairment
-Pregnant or lactating
-Cognitive impairment (3MS score < 79)
-History of neurological or psychiatric disorders

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analyses will be performed using SPSS version 25. Statistical significance will be set at p < 0.05. Regression analyses will be undertaken in order to compare vitamin C concentrations with cognitive performance before and after surgery. A repeated measures t-test will be used to determine any vitamin concentration and cognitive changes between testing sessions. Descriptive analysis will be conducted on all study variables collected at each testing session.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2020
Actual
Date of last participant enrolment
Anticipated
20/11/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14522 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 27536 0
3122 - Hawthorn
Recruitment postcode(s) [2] 27537 0
3181 - Windsor

Funding & Sponsors
Funding source category [1] 303531 0
Other Collaborative groups
Name [1] 303531 0
National Institute of Integrative Medicine (NIIM)
Country [1] 303531 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Institute of Integrative Medicine (NIIM)
Address
21 Burwood rd, Victoria, Hawthorn, 3122
Country
Australia
Secondary sponsor category [1] 303597 0
None
Name [1] 303597 0
Address [1] 303597 0
Country [1] 303597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304058 0
The Avenue Hospital Human Research Ethics Committee
Ethics committee address [1] 304058 0
40 The Avenue, Windsor VIC 3181
Ethics committee country [1] 304058 0
Australia
Date submitted for ethics approval [1] 304058 0
19/02/2019
Approval date [1] 304058 0
18/06/2019
Ethics approval number [1] 304058 0
265
Ethics committee name [2] 304065 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics committee
Ethics committee address [2] 304065 0
21 Burwood rd, Hawthorn, Victoria, 3122
Ethics committee country [2] 304065 0
Australia
Date submitted for ethics approval [2] 304065 0
16/11/2016
Approval date [2] 304065 0
30/11/2016
Ethics approval number [2] 304065 0
0038N_2016

Summary
Brief summary
The present study is designed to explore a link between cognitive decline post-surgery as a cause of vitamin C decline following the surgery. The aim of the study is to to determine whether surgery has an effect on vitamin C levels and cognition with the use of a neuropsychological test battery. It is hypothesised that elective hip surgery will result in significantly depleted plasma vitamin C concentrations which will contribute to compromised cognitive function on the cognitive assessments.
Cognitive tests will involve both paper and pen and computer tests, while blood tests will be undertaken to measure plasma vitamin C and serum vitamin B12 levels and levels of inflammation.
Testing will be conducted roughly 1-2 weeks prior to the scheduled surgery and subsequent testing sessions will be performed within 1 week, 4-6 weeks, 3 months and 6 months after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95678 0
Mr Nikolaj Travica
Address 95678 0
21 Burwood rd, Hawthorn, Victoria, 3122.
Work organisation: National Institute of Integrative Medicine (NIIM).
Country 95678 0
Australia
Phone 95678 0
+61 3 9912 9544
Fax 95678 0
Email 95678 0
ntravica@niim.com.au
Contact person for public queries
Name 95679 0
Nikolaj Travica
Address 95679 0
21 Burwood rd, Hawthorn, Victoria, 3122.
Work organisation: National Institute of Integrative Medicine (NIIM).
Country 95679 0
Australia
Phone 95679 0
+61 3 9912 9544
Fax 95679 0
Email 95679 0
ntravica@niim.com.au
Contact person for scientific queries
Name 95680 0
Nikolaj Travica
Address 95680 0
21 Burwood rd, Hawthorn, Victoria, 3122.
Work organisation: National Institute of Integrative Medicine (NIIM).
Country 95680 0
Australia
Phone 95680 0
+61 3 9912 9544
Fax 95680 0
Email 95680 0
ntravica@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3996Study protocol    378155-(Uploaded-12-08-2019-15-09-39)-Study-related document.docx
3997Ethical approval    378155-(Uploaded-12-08-2019-15-10-41)-Study-related document.pdf
3998Informed consent form    378155-(Uploaded-12-08-2019-15-11-51)-Study-related document.docx



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.