VITDALIZE UK

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The VITDALIZE UK Trial: The effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: the UK arm of an international multi-centre, placebo-controlled double-blind trial.

 

 

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The VITDALIZE UK Trial forms part of a large international randomised controlled trial to determine if treatment with a high dose of vitamin D improves patient outcomes and is cost-effective in comparison to the placebo in severely vitamin D deficient critically ill patients admitted to an intensive care unit. 

The VITDALIZE UK study is funded by the National Institute for Health Research (NIHR).

The VITDALIZE Trial is currently being conducted in the UK, Austria, Belgium and Germany.

If you are hospital site and are interested in participating in the VITDALIZE UK Trial please contact us: vitdalize@trials.bham.ac.uk

Design

The VITDALIZE UK trial is the UK arm of a large international randomised double blind placebo controlled trial.  Patients will be randomised to the intervention (Vitamin D) or control arm (Placebo).

Aim of Study

The primary objective of this trial is to determine whether testing for and treating severe VDD with high dose oral vitamin D3 replacement in adult critically ill patient’s decreases 28-day mortality.

Setting

 Hospital Critical Care Units.

Target Population

The target population are adult critically ill patients (≥18 years) admitted to an intensive care unit suffering with severe vitamin D deficiency.

The target sample size for the UK is 600.

Intervention

The interventions the participant will receive shall be either: 

A single loading high-dose oral/enteral vitamin D3 followed by a maintenance dose of vitamin D for 90 days.

Or

Placebo, identical regime of loading dose of medium chain triglycerides (MCT) followed by a maintenance dose of MCT daily for 90 days.

The views expressed are those of the authors and not necessarily those of the NHS, NIHR or the Department of Health.

Privacy Statement

Will my details be kept confidential?

All information collected about you for this trial will be subject to the General Data Protection Regulation (GDPR) and Data Protection Act 2018 for health and care research and will be kept strictly confidential. Data collected in the UK for the VITDALIZE UK Trial by the NCC or UK hospitals is the exclusive property of the NCC. The NCC will be using information from your medical records in order to undertake this trial and will act as the data controller. This means that the NCC are responsible for looking after your information and using it properly. The NCC and the NHS will keep identifiable information about you for at least 25 years after the trial has finished to allow the results of the trial to be verified if needed. 

All information collected by the NCC will be securely stored in the VITDALIZE UK Trial Office at the University of Birmingham on paper and electronically, and will only be accessible by authorised personnel. The only people in the University of Birmingham who will have access to information that identifies you will be people who manage the trial or audit the data collection process. There is an open-access VITDALIZE UK Trial website www.birmingham.ac.uk/vitdalizeuk that contains information about the trial. No identifiable information about you will be available on this website.  

The NHS will use your name and contact details to contact you about the research trial and make sure that relevant information about the trial is recorded for your care, and to oversee the quality of the trial. With your permission, a copy of your signed consent form will also be sent to the University of Birmingham as the NCC in the UK for this trial. 

At the VITDALIZE UK Trial Office, you will be identified by a unique trial number. In routine communication between your hospital and the VITDALIZE UK Trial Office, you will be identified by trial number, initials and date of birth. Data may be provided to the VITDALIZE UK Trial Office on paper or electronically. 

By taking part in the trial, you will be agreeing to allow research staff from the VITDALIZE UK Trial Office to look at the trial records, including your medical records. It may be necessary to allow authorised personnel from government regulatory agencies (e.g. Medicines and Healthcare Products Regulatory Agency (MHRA), the Sponsor, the NCC and/or NHS bodies to have access to your medical and research records. This is to ensure that the trial is being conducted to the highest possible standards. 

The data collected for all participants in the VITDALIZE UK Trial will be used by the Sponsor (Medical University of Graz) and international collaborators in the European Union (EU) in compliance with the current data transfer regulations. The data transferred will be pseudo-anonymised and comprise your trial number, age and sex.   

From time to time, we may be asked to share the trial information (data) we have collected with researchers running other studies in this organisation and in other organisations so that they can perform analysis on the data to answer other important questions about critical illness and vitamin D deficiency. These organisations may be universities, NHS organisations or companies involved in health research and may be in this country or abroad. Any such request is carefully considered by the trial researchers and will only be granted if the necessary procedures and approvals are in place. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health research and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance. Under no circumstances will you be identified in any way in any report, presentation or publication arising from this or any other trial. 

To allow accurate follow up of all participants it will be necessary for the VITDALIZE UK Trial Office to contact other UK NHS bodies to provide information about your health. This would mean that the VITDALIZE UK Trial Office would use some of your personal identifiers (date of birth, NHS number (CHI number for patients in Scotland, H&C numbers for patients in Northern Ireland), trial number, age and sex. Your information will be held and maintained by central UK NHS bodies such as NHS digital. 

All individuals who have access to your information have a duty of confidentiality to you. Your rights to access change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. To safeguard your rights, we will use the minimum personally identifiable information possible.  Under the provisions of the GDPR 2018, you have the right to know what information the VITDALIZE UK Trial Office has recorded about you. If you wish to view this information or find more about how we use this information, please contact Legal Services at the address below. Please note that a small fee may be payable to retrieve this information. 

Legal Services University of Birmingham Edgbaston Birmingham, B15 2TT