ANZCTR - Registration

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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]

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

Frailty

Condition category

Condition code

Diet and Nutrition

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At the first encounter with an eligible consenting patient (once off)

Primary outcome [2]

To determine whether frail patients who are vitamin C deficient have longer length of stay in hospital

Timepoint [2]

Single occasion in each participant- case notes follow up

Primary outcome [3]

Determine if frail patients with vitamin C deficiency have higher mortality

Timepoint [3]

Single occasion- follow-up of case notes

Secondary outcome [1]

Determine if frail patients with vitamin C deficiency have more complications during admission

Timepoint [1]

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?

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)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Flinders Medical Centre, SALHN

Address [1]

Flinders Drive, Bedford Park 5042 SA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive, Bedford Park, 5042, SA

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC EC00188)

Ethics committee address [1]

Flinders Drive, Bedford Park 5042 SA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/02/2019

Approval date [1]

09/08/2019

Ethics approval number [1]

OFR Number: 64.19 HREC reference number: HREC/19/SAC/72

Summary

Brief summary

We hypothesize that acutely hospitalized frail patients may have vitamin C deficiency and this could be associated with poorer outcomes during inpatient stay (longer LOS, higher mortality, complications etc). This study aims to look prospectively for an association  between vitamin C deficiency and frailty, which hasn't been evaluated in the past and if this is demonstarted,this can pave the way to future research to determine new treatment options for frail patients.

Trial website

Trial related presentations / publications

Public notes

Literature review: 
The prevalence of frailty in acutely hospitalised older patients can be up to 48% (1) and frail patients have poor clinical outcomes measured in terms of increased mortality, poor health related quality of life (HRQoL) and higher number of unplanned readmissions(.2,3). Studies suggest that oxidative stress may be associated with frailty and preliminary evidence points to lower anti-oxidant parameters in frail patients.(4) Vitamin C acts as a powerful anti-oxidant but whether vitamin C deficiency is associated with frailty has not yet been established.(5). Although research has indicated that low intake of vitamin C may increase risk of frailty, limited studies have verified this hypothesis by measuring plasma vitamin C levels, which is regarded as a more accurate assessment of vitamin C status.(6 0Previous studies have also suggested that other micronutrient deficiency (especially vitamin D and vitamin B12 deficiency) may be associated with frailty but the relationship between biochemical vitamin C deficiency and frailty is unclear.(6) A recent study has also suggested that two-third of hospitalised patients may have biochemical vitamin C deficiency.(7) This research will therefore explore the relationship between plasma vitamin C levels and frailty in acutely hospitalised older general medical patients and will determine whether frail patients have a higher prevalence of vitamin C deficiency. This study will also determine whether frail patients who are vitamin C deficient have poorer clinical outcomes as compared to those who are vitamin C replete.

References:
1. Ibrahim K, Howson FFA, Culliford DJ, Sayer AA, Roberts HC. The 
feasibility of assessing frailty and sarcopenia in hospitalised older people: a comparison of commonly used tools. BMC Geriatr 2019;19(1):42.
2. Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet 2013;381(9868):752-62.
3. Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R et al. Frailty consensus: a call to action. J Am Med Dir Assoc 2013;14(6):392-7.
4. Soysal P, Ahmet TS, Andre FC, Fernandes BS, Solmi M, Schofield P et al. Oxidative stress and frailty: A systematic review and synthesis of the best evidence. Maturitas 2017;99: 66-72.
5. Hemila H, Chalker E. Vitamin C can shorten the length of stay in the ICU: A meta-analysis. Nutrients 2019; 11(4):pii:E708.
6. Semba RD, Bartali B, Zhou J, Blaum C, Ko CW, Fried LP. Low serum micronutrient concentrations predict frailty among older women living in the community. J Gerontol A Biol Sci Med Sci 2006;61(6):594-9.
7. Sharma Y, Miller M, Shahi R, Doyle A, Horwood C, Hakendorf P et al. Vitamin C deficiency in Australian hospitalized patients: an observational study. Intern Med J 2018

Contacts

Principal investigator

Name

Dr Yogesh Sharma

Address

Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA

Country

Australia

Phone

+61 882045511

Fax

Yogesh.Sharma@sa.gov.au

Contact person for public queries

Name

Alexandra Popescu

Address

Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA

Country

Australia

Phone

+61 882045511

Fax

Alexandra.Popescu@sa.gov.au

Contact person for scientific queries

Name

Alexandra Popescu

Address

Flinders Medical Centre, Flinders Drive, Bedford Park, 5042 SA

Country

Australia

Phone

+61 882045511

Fax

Alexandra.Popescu@sa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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