Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05122481 |
| Other study ID # |
2-061-21 |
| Secondary ID |
296819 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2023 |
| Est. completion date |
July 30, 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of Aberdeen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Older people in care homes are one of the most vulnerable groups with respect to risk,
morbidity and mortality of severe coronavirus disease-2019 (COVID-19). In the UK, almost half
(47%) of all COVID-19 deaths occurred in care homes. The World Health Organization (WHO) has
highlighted vitamin C as an adjunctive therapy with biological plausibility for people with
severe COVID-19. Previous research has indicated that up to 40% of care home residents in the
UK are deficient in vitamin C, an essential immune supportive nutrient. This is a 10-fold
higher deficiency level than that reported in community dwelling older people in the UK
government's National Diet and Nutrition Survey.
Due to lack of robust pharmacokinetic data in older people, the intake required to optimise
the vitamin C status of this cohort is not yet known and may be higher than that for healthy
adults; some have estimated as high as 400 mg/d (the current UK recommended nutrient intake
(RNI) or vitamin C is 40 mg/d, which is sufficient to prevent deficiency, but not enough for
optimal/saturating vitamin C status). Thus, this pilot and feasibility study will assess the
intake requirements of care home residents for optimal vitamin C status. The purpose is to
provide essential data for a future clinical trial assessing the efficacy of optimal vitamin
C supplementation for risk, severity, and duration of respiratory infections in this
population who are at risk of such infections.
Description:
This is a pilot dose-finding study comprising 20 older people ENRICH-listed care home
residents (aged 65+). The feasibility of a larger study and a future trial recruitment will
also be assessed.
The investigators will invite care homes to participate in the study by approaching care
homes that have expressed interest in hosting research studies as research sites via care
home network ENRICH (https://enrich.nihr.ac.uk/joining-the-network/). Flyers will also be
provided (VitaC4Care_ V.3 _14.09.21_ Flyer) to raise interest.
Each participant, with the assistance of a care home staff member, will complete a two-part
questionnaire at the beginning of the study and at the end. The first part of the
questionnaire will include recordings of age, weight/height, date of admission to care home
and date of completion of the present questionnaire, co-morbidities (specifically
hypertension, diabetes, previous cerebrovascular accident or myocardial infarction,
arthritis, Chronic obstructive pulmonary disease or asthma, active malignancy, and type),
regular medication (specifically omeprazole, diabetic medication and type, aspirin, diuretics
and type, and statins). The first-part questionnaire will include free text spaces for the
addition of other comorbidities or medications not mentioned above. For the second part of
the questionnaire, the participant will be required to complete a symptom record for the
following symptoms: arthralgia (lay language as per patient questionnaire: sore joints),
myalgia (sore muscles) ankle edema (puffy ankles), loss of appetite, peripheral paresthesia
(pins and needles at hands or legs), dizziness, shortness of breath, malaise (tiredness), low
mood, irritability. The participant will be required to state how often they experience these
symptoms on a scale from 1 (Never) to 5 (All the time). The same questionnaire will be
offered to the participants at the end of the study and symptom improvement, or deterioration
will be recorded on a numerical scale. Furthermore, each participant (assisted by care home
staff) will provide twelve urine samples over the course of up to four weeks which will be
analysed for vitamin C content using a urine vitamin C test strip (VitaChek-C, Teco
Diagnostics, USA) and creatinine/protein/Specific Gravity ((HomeHealth, UK). There will be
six designated test days and the rest of the study period will be made up of break days when
no samples will be collected. After each test day, three break days will be allowed to ensure
participant comfort. If on a "testing" day, a second urine sample is not obtained, the same
supplement concentration will be provided on the next "testing" day to ensure data
completion.
On the test days, the participant will be asked to provide a urine sample before taking the
supplement (Vitamin C 5000, NutriVital Food Supplement, made in UK by NutriVital Health,
nutrivital.co.uk), this sample will be used as a baseline and assessed for Vitamin C and
creatinine/protein and specific gravity, with the same testing strips as mentioned above.
Once collected, the participant will be provided with a drink containing an increasing daily
dose of vitamin C (0 - 500 mg; see study schedule in 3.2). The supplement will be
encapsulated and either consumed as a pill or dissolved in a room temperature water drink
prior to consumption.
A second urine sample will then be collected approx. 3 - 4 hours later to assess the extent
of vitamin C excretion in urine with an increase in vitamin C supplement. Another urine test
strip will also be used to determine creatinine concentrations (to standardize vitamin C
values), presence of albumin/protein (to determine kidney function) and specific gravity (to
determine urine concentration).
The absence of vitamin C in the urine or minimal change in excretion indicates that the blood
is not yet saturated. In which case, the next dose will be given the following day.
Additional information on vitamin C dietary intake will be estimated by accessing the weekly
care home menu, individual choice of menu and record of drink/food brought to care home
residents by visitors. Information on demographics, length of time in care home,
co-morbidities, and medications as documented in the care home records will also be
collected.
This pilot study will provide the following information for power calculations for a larger
study (future clinical trial):
1. the proportion of eligible older adults with inadequate vitamin C status
2. the minimum dose of vitamin C required to optimize plasma vitamin C status in this
cohort To achieve the secondary objectives, information on the key aspects of
feasibility for a larger study will be collected as described in the secondary
objectives section (future clinical trial).
At the end of the study, a questionnaire will be disseminated to participants, their carers,
relevant managers and care home staff to assess the willingness to participate in a bigger
research trial and to identify any issues to be addressed to gain support for such an
intervention trial. The questionnaire will be sent out to 31 individuals and will not collect
any identifiable data. The recipient will have state their level of involvement to the study
(e.g. participant, care home staff, care home manager, other (with free text).
