Vitamin D supplementation and/or positive mood intervention after vaccination Infections and Infestations
Conditions
Interventions
This is a feasibility study to identify compliance and adherence to vitamin D for 28 days from the day of vaccination and a positive mood intervention for 7 days from the day of vaccination.
Patient
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent to participate in the study 2. Able and willing (in the investigator’s opinion) to comply with all the study requirements 3. Consent to allow investigators to discuss their medical information with their general practitioner and access medical records where relevant to the study 4. Eligible to receive a COVID-19 vaccination and/or influenza vaccination as part of usual care
Exclusion criteria
Exclusion criteria: 1. Enrolled on a COVID-19 vaccine clinical trial of an investigational medicinal product (CTIMP) in the last 12 months 2. Clinically extremely vulnerable and received a third or fourth dose in Spring 2022 3. Aged less than 65 years old 4. Ineligible to receive a COVID-19 and/or influenza vaccination as part of usual care or those for whom a COVID-19 and/or influenza vaccination is contraindicated 5. Collection of blood samples is contraindicated 6. Deemed by health care provider to be: 6.1. Too physically frail to participate. 6.2. Diagnosed with dementia or other cognitive condition which would make participation difficult 6.3. Insufficient command of the English language to complete surveys and provide informed consent 6.4. Participants who, in the past 3 months, have been prescribed oral vitamin D supplementation by a health care professional or who take over-the-counter supplements regularly on the advice of a health care professional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance with study procedures measured using an e-diary from day 1 to day 28 Adherence to study procedures measured using an e-diary from day 1 to day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine-induced influenza antibody titres measured using an ELISA test at baseline and day 28 | — |
Countries
England, United Kingdom
Contacts
Public ContactSimon Royal
Outcome results
None listed