Trial Review

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
ACTRN12617000022369
Ethics application status
Approved
Date submitted
29/12/2016
Date registered
9/01/2017
Date last updated
9/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin C levels in hospitalised patients
Scientific title
Vitamin C levels in hospitalised patients
Secondary ID [1] 290739 0
None
Universal Trial Number (UTN)
U1111-1190-8854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin C deficiency 301318 0
Condition category
Condition code
Diet and Nutrition 301073 301073 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To determine Vitamin C levels in patients admitted under General Medicine. Blood sample will be collected once at admission for determination of Vitamin C levels.
Intervention code [1] 296645 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300608 0
Prevalence of Vitamin C deficiency in general medical hospitalised patients. Vitamin C levels will be determined in blood samples taken at the time of hospital admission.
Timepoint [1] 300608 0
Once following enrolment of participants.
Secondary outcome [1] 330404 0
Quality of life as determined by EQ5D (European Quality of Life) questionnaire
Timepoint [1] 330404 0
Once following enrolment of participants.
Secondary outcome [2] 330405 0
association with cognitive decline assessed by Mini-Mental State Examination (MMSE).
Timepoint [2] 330405 0
Once following enrolment of participants.
Secondary outcome [3] 330406 0
Length of hospital stay will be recorded from hospital admission database.
Timepoint [3] 330406 0
At the time of hospital discharge.
Secondary outcome [4] 330407 0
association with the Nutrition status assessed by Malnutrition Universal Screening Tool (MUST).
Timepoint [4] 330407 0
Once following enrolment of participants.

Eligibility
Key inclusion criteria
All patients admitted under General Medicine
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of valid consent

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Basic descriptive statistics will be used to describe patients' characteristics and sk test will be utilized to test normality of variables. The continuous variables will be expressed as mean (SD) or median (Inter quartile range) and categorical variables as n (%) and student t test or Mann Whitney U test will be used to analyze continuous variables and categorical variables will be assessed using chi2 or Fisher's exact test where appropriate. Regression models will be used to test association of Vitamin C deficiency with cognitive status with adjustment for any confounding variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7179 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 14941 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 295240 0
Hospital
Name [1] 295240 0
Flinders Medical Centre
Country [1] 295240 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 294067 0
None
Name [1] 294067 0
Address [1] 294067 0
Country [1] 294067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296579 0
Southern Adelaide Human Research Ethics Committee
Ethics committee address [1] 296579 0
SAHLAN Office for Research
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 296579 0
Australia
Date submitted for ethics approval [1] 296579 0
Approval date [1] 296579 0
27/05/2016
Ethics approval number [1] 296579 0
HREC/15/SAC/361 401.15

Summary
Brief summary
It is well known that severe Vitamin C deficiency can lead to gum disease, bleeding and poor wound healing but the effect of mild to moderately low levels in hospitalised patients is less known. This research endeavours to review the effect of Vitamin C deficiency in the unwell person and how it affects recovery. The aims of the present study is to examine Vitamin C levels in hospitalised patients and determine possible correlation with cognition, severity of illness and clinical course in hospital. This study will involve addition of Vitamin C levels in blood samples after informed consent from the patients, admitted in General Medicine Department of Flinders Medical Centre. The nutrition status of the participants will be determined using Malnutirition Universal Screening Tool (MUST) and quality of life will be assessed using European Quality of life Questionnaire (EQ5D). The patients will be followed onto the discharge for development of complications during hospital stay and hospital lenght of stay will be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71134 0
Dr Yogesh Sharma
Address 71134 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Country 71134 0
Australia
Phone 71134 0
+61882046694
Fax 71134 0
Email 71134 0
[email protected]
Contact person for public queries
Name 71135 0
Dr Yogesh Sharma
Address 71135 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Country 71135 0
Australia
Phone 71135 0
+61882046694
Fax 71135 0
Email 71135 0
[email protected]
Contact person for scientific queries
Name 71136 0
Dr Yogesh Sharma
Address 71136 0
Department of General Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Country 71136 0
Australia
Phone 71136 0
+61882046694
Fax 71136 0
Email 71136 0
[email protected]

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.