Document is current

Article History

Received: 20 August 2024

Accepted: 22 December 2024

First Online: 19 February 2025

Declarations

:

: Research ethics approvalThis clinical trial has been approved by the King’s College, London Research Ethics Committee (KCL-REC) [Reference Number: HR/DP-22/23-34078, Study Title: TransVitD]. Any protocol amendments will be submitted to King’s College REC for approval. The trial will comply with good clinical practice guidelines over the reporting of adverse events (AEs), serious adverse events (SAEs), and suspected serious adverse reactions (SUSARs) as well as providing the REC with progress reports and final study report.Patient or participant protocol involvementThere was no patient or participant involvement in the study protocol design.Protocol amendmentsIf amendments to this protocol are required, approval will be sought from the KCL-REC and updated protocol will be made available on request. This protocol version is 1.5, 10th October 2024. The PI will notify the trial sponsor, funders, and trial centre clinical teams of any protocol changes. In addition, a copy of the revised protocol will be added to the Investigator Site File and the consent forms and clinical trial registry entry will be amended to reflect the changes.

: All participants have agreed to the publication of these results.

: SAJ is the inventor of the vitamin D phosphate patent WO2022084669A1. MAA and SAJ have received funding to develop and test the vitamin D patch in preclinical studies from Vitamax Patch Wholesaler LLC.