Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000655943
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
5/06/2020
Date last updated
12/10/2021
Date data sharing statement initially provided
5/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between vitamin C deficiency and frailty in acutely hospitalized patients
Scientific title
Association between vitamin C deficiency and frailty in elderly patients aged 75 and above admitted in the acute medical wards
Secondary ID [1] 301181 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Vitamin C deficiency
 317330 0
Frailty 317331 0
Condition category
Condition code
Diet and Nutrition 315439 315439 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
Patients will be approached by the research team members in order to provide consent for blood test sample to measure vitamin C; an information sheet will be provided explaining the trial, its aims and the possibility of withdrawing at any time. There will be only a once off encounter with the patient permitting full assessment of frailty and measure confounding factors. Patients, if deemed to have capacity to consent, or guardians of patients, will be allowed to make an informed consent.
Intervention code [1] 317493 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323689 0
We expect to determine the prevalence of vitamin C deficiency amongst frail elderly inpatients, assessed by morning serum measurement of vitamin C level
Timepoint [1] 323689 0
At the first encounter with an eligible consenting patient (once off)
Primary outcome [2] 323691 0
To determine whether frail patients who are vitamin C deficient have longer length of stay in hospital
Timepoint [2] 323691 0
Single occasion in each participant- case notes follow up
Primary outcome [3] 323913 0
Determine if frail patients with vitamin C deficiency have higher mortality
Timepoint [3] 323913 0
Single occasion- follow-up of case notes
Secondary outcome [1] 383321 0
Determine if frail patients with vitamin C deficiency have more complications during admission
Timepoint [1] 383321 0
Once-off- review of case notes

Eligibility
Key inclusion criteria
A member of the research team will approach the participants and a written informed consent will be obtained from the participants. In case of cognitive impairment, the decision regarding participants’ capacity will be made from their mini mental state examination (MMSE) scores. For this study, we will only approach those patients > 75 yo referred by ED to General Medicnie acute admission with a score of 19 to 24 on the MMSE. An MMSE score of 19-24 indicates mild cognitive impairment, but given the low complexity of this project, patients would still be expected to have capacity and consent for themselves. Patients with MMSE below 19 will be excluded on the basis that they will be unable to provide informed consent for themselves. We will adhere to recommendations from Black et al (9) regarding assessment of verbal, behavioural, and emotional cues expressing comprehension and assent
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Vitamin C treatment/supplementation
Palliative patients
Lack of valid consent
Reluctance to participate or hesitancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size was calculated on the basis of logistic regression analysis (outcome variable vitamin C replete equal 0 and vitamin C deficient equals 1), for which we only need the following co-variates:
Age (in years)
Sex
Charlson index
MUST (Malnutrition universal screening tool) score
Determination of sample size for logistic regression studies is a complex problem, so applying the guidelines suggested above and based on a recent study7, which has suggested that two-thirds of older hospitalised patients have vitamin C deficiency, assuming that 25% of older will be vitamin C replete and the number of co-variates equal 4 (age, sex, Charlson index and MUST score) a minimum of 160 will be required.
N = 10 X 4/0.25 equal 160
We will adjust for potential confounders by including age, sex, Charlson index and MUST score as co-variates in the logistic regression analyses of the ‘primary’ and ‘secondary’ outcomes. As there will be minimal involvement of patients with no collection of data for follow-up visits, the rate of withdrawal is expected to be negligible; should a patient choose to withdraw from the study then the associated data will be deleted and a replacement participant will be sought.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/05/2020
Date of last participant enrolment
Anticipated
30/10/2020
Actual
31/12/2020
Date of last data collection
Anticipated
13/11/2020
Actual
31/12/2020
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16601 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30198 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305638 0
Hospital
Name [1] 305638 0
Flinders Medical Centre, SALHN
Country [1] 305638 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive, Bedford Park, 5042, SA
Country
Australia
Secondary sponsor category [1] 306038 0
None
Name [1] 306038 0
Address [1] 306038 0
Country [1] 306038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305920 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC EC00188)
Ethics committee address [1] 305920 0
Ethics committee country [1] 305920 0
Australia
Date submitted for ethics approval [1] 305920 0
22/02/2019
Approval date [1] 305920 0
09/08/2019
Ethics approval number [1] 305920 0
OFR Number: 64.19 HREC reference number: HREC/19/SAC/72

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102066 0
Dr Yogesh Sharma
Address 102066 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA
Country 102066 0
Australia
Phone 102066 0
+61 882045511
Fax 102066 0
Email 102066 0
[email protected]
Contact person for public queries
Name 102067 0
Alexandra Popescu
Address 102067 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA
Country 102067 0
Australia
Phone 102067 0
+61 882045511
Fax 102067 0
Email 102067 0
[email protected]
Contact person for scientific queries
Name 102068 0
Alexandra Popescu
Address 102068 0
Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA
Country 102068 0
Australia
Phone 102068 0
+61 882045511
Fax 102068 0
Email 102068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have any plans to share the data and any follow-up research will need an ethical approval


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.