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Trial registered on ANZCTR

Registration number

ACTRN12615001140549

Ethics application status

Approved

Date submitted

13/10/2015

Date registered

27/10/2015

Date last updated

3/10/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Correlation between Plasma Vitamin C Levels and Cognition: A Cross-Sectional Study

Scientific title

Correlation between Plasma Vitamin C Levels and Cognition in healthy adults.
Title was changed as a result of only healthy aduts being recruited. Surgery patients will be recruited in another trial, down the track. This was changed very early in the present trial when it was agreed that surgery patients will be recruited for a seperate trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Brain Health

Cognition

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Participants will have their fasting plasma Vitamin C and serum vitamin B12 levels measured. Blood is taken after a series of cognitive tests arte undetaken. Due to laboratory testing of vitamin C concentrations being conducted on plasma specimens, plasma was collected. This was done from the onset of the trail.
Cognitive testing will be conducted prior to the blood test. Cognition will be assessed over one and a half hours using pen and paper tests as well as a computerized testing battery ( SUCCAB) (Pipingas, 2010).

Intervention code [1]

Not applicable

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Fasting ( 10 hours) plasma vitamin C levels. Eliza testing in which a plasma essay will be used to determine concentrations as well as a pathology company.

Timepoint [1]

This will be tested as soon as possible following cognitve assessments

Primary outcome [2]

Cognition assessed using the Computerised Swinburne University Computerised Cognitive Assessment Battery (SUCCAB) (Pipingas et al., 2010, Current Topics in Nutraceutical Research, Vol. 8, No. 2/3).

Timepoint [2]

The study is a cross-sectional design. Participants will be tested at one time point and will have their blood taken and cognition assessed at one time point.

Secondary outcome [1]

Fasting serum vitamin B12 concentrations. Eliza testing in which a serum essay will be used to determine concentrations as well as a pathology company.

Timepoint [1]

The study is a cross-sectional design. Participants will be tested at one time point and will have their blood taken and cognition assessed at one time point.

Secondary outcome [2]

Cognition assessed using a number of Pen and paper tests. These include the symbol digit modalities test (SDMT) and Hopkins Verbal learning test (HVLT-R).

Timepoint [2]

The study is a cross-sectional design. Participants will be tested at one time point and will have their blood taken and cognition assessed at one time point.

Eligibility

Key inclusion criteria

- 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.
- Seeking primarily patients with low vitamin C levels (below 23 micromoles per litre).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Poor comprehension of written or spoken English
- Taking antidepressants, antipsychotics, anxiolytics, illicit drugs or any cognitive enhancing drugs.
- Pregnant or lactating
- Colour blindness or any other severe visual impairment.

Study design

Purpose

Psychosocial

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

A sample size calculation indicated that 80 participants was sufficient to detect a significant mean difference of 100 milliseconds (SD=211) on the spatial working memory reaction time task in the SUCCAB, with 80% power and 95% confidence. This Difference is correlated to about 10 years of age difference.(Pipingas et al., 2010, Current Topics in Nutraceutical Research, p.82, Vol. 8, No. 2/3 ).
Analyses will be performed using SPSS version 22.0 and SAS version 9.2. Statistical significance will be set at p < 0.05. Analyses will involve correlations and ANCOVAs between the cognitive scores of normal and low vitamin C status participants.
Descriptive analysis will be conducted on all study variables collected at baseline.
Regression analyses will be undertaken in order to compare vitamin C concentrations with cognitive performance. Additionally, cognitive performance will be correlated with population averages and paper and pen cognitive tests ( HVLT-R and SDMT) will be correlated with the SUCCAB.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

2/11/2015

Actual

5/11/2015

Date of last participant enrolment

Anticipated

12/12/2016

Actual

12/07/2017

Date of last data collection

Anticipated

Actual

12/07/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3122 - Hawthorn

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

National Institute of Integrative Medicine (NIIM)

Address [1]

21 Burwood Rd, Hawthorn, Vic, 3122

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

National Institute of Integrative Medicine (NIIM)

Address

21 Burwood Rd, Hawthorn, Vic, 3122

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Institute of Integrative Medicine Human Research Ethics Committee

Ethics committee address [1]

21 Burwood rd, Hawthorn, Vic, 3122

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/07/2015

Approval date [1]

03/08/2015

Ethics approval number [1]

0025N_2015

Summary

Brief summary

Low plasma vitamin C and E have been more likely to be found in demented patients than in healthy controls. This is supported by findings from a prospective cohort study from Department of Health/Medical Research Council Nutritional Programme in which participants (n = 921; greater than or equal to 65 years) with the lowest Vitamin C status displayed the poorest cognitive function, a finding which persisted when corrected for age, illness, social class, or other dietary variables.  Additionally, a recent an epidemiological prospective cohort study showed that high dietary intake of vitamin C and vitamin E may lower the risk of Alzheimer disease. Higher vitamin C blood levels have been found in association with a better memory performance among subjects older than 65 years.
Studies have shown that blood vitamin C concentration falls during acute phase responses such as after surgery, trauma, sepsis, and burns. Researchers at the University of Toronto have shown that anaesthetics following surgery can cause long-term memory loss. In a recent study, blood concentration of vitamin C decreased post-operatively and the reduction was significant 7 days after coronary heart surgery.
A study is yet to correlate  paper and pen assessments such as the Mini mental State Examination (MMSE), Hopkins Verbal Learning test (HVLT-R)  and symbol digit modalities test (SDMT)  with a computer based cognitive testing such as the SUCCAB. The SUCCAB assesses accuracy and speed, which have been shown to correlate to cognitive decline through ageing. There is consensus that crystallised abilities (vocabulary and general knowledge) can remain stable until very late in life whereas fluid abilities (attention, executive function and memory) decline from middle adulthood until late age. The cognitive tests incorporated in the present study will primarily examine these fluid abilities. The MMSE assesses cognitive impairments in clinical and research settings. The HVLT-R is a reliable neuropsychological test of many aspects of verbal learning and memory, requiring subjects to recall as many items as possible from a list of common words. The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. 
Previous research measuring vitamin C has incorporated simple food questionnaires to predict vitamin C levels. The proposed study will measure serum vitamin C levels thoroughly through a means of ELISA testing. The proposed project aims to examine vitamin C serum concentration and cognitive performance measured by SUCCAB, and the pen and paper tests, including the MMSE, SDMT, and HVLT-R.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Nikolaj Travica

Address

National Institute of Integrative Medicine (NIIM)
21 Burwood rd, Hawthorn,VIC, 3122

Country

Australia

Phone

+61 421115453

Fax

ntravica@niim.com.au

Contact person for public queries

Name

Nikolaj Travica

Address

National Institute of Integrative Medicine (NIIM)
21 Burwood Rd, Hawthorn,VIC, 3122

Country

Australia

Phone

+61 421115453

Fax

ntravica@niim.com.au

Contact person for scientific queries

Name

Nikolaj Travica

Address

National Institute of Integrative Medicine (NIIM)
21 Burwood Rd, Hawthorn, VIC, 3122

Country

Australia

Phone

+61 421115453

Fax

ntravica@niim.com.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

Source	Title	Year of Publication	DOI
Embase	Gender differences in plasma vitamin C concentrations and cognitive function: A pilot cross-sectional study in healthy adults.	2020	https://dx.doi.org/10.1093/CDN/NZAA038

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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