PROTECTIVE-D: imPROving the effecTivenEss of vaccinaTion wIth positive mood and Vitamin D

Not Applicable

Completed

• Conditions: Vitamin D supplementation and/or positive mood intervention after vaccination; Infections and Infestations

• Registration Number: ISRCTN12950625
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-01
• Study Start: 2024-02-08
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance with study procedures measured using an e-diary from day 1 to day 28<br>Adherence to study procedures measured using an e-diary from day 1 to day 28<br><br>

Secondary Outcome Measures

Name	Time	Method
Vaccine-induced influenza antibody titres measured using an ELISA test at baseline and day 28