ISRCTN12950625
Completed
未知
A feasibility randomised controlled trial examining the effect of a positive mood intervention and vitamin D supplementation on the immunological responses to a boosting COVID-19 and/or influenza vaccination in healthy adults
niversity of Nottingham0 sites28 target enrollmentFebruary 8, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Vitamin D supplementation and/or positive mood intervention after vaccination
- Sponsor
- niversity of Nottingham
- Enrollment
- 28
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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