Plain English Summary
Background and study aims
Oesophagectomy is the surgical removal of the oesophagus (food pipe), for example to remove oesophageal cancer. Sometimes following oesophagectomy the lungs become inflamed - a condition that is called acute lung injury. This happens about 28% of the time following oesophagectomy and the causes for it are poorly understood. The condition can range in severity from causing mild breathlessness to more severe breathlessness that can require assistance from a ventilator (breathing machine) to help with breathing in intensive care. We believe that people who are severely vitamin D deficient may be more at risk of acute lung injury following the operation than those who are not. We have previously done research which suggests that people who need an oesophagectomy are usually vitamin D deficient with about half being very deficient. We have evidence from our previous studies that those with the lowest levels of vitamin D may be at increased risk of inflammation and acute lung injury. The aim of this study is to determine whether we can restore vitamin D levels rapidly in the week or so prior to surgery using a single dose of liquid vitamin D taken by mouth.
Who can participate?
Patients aged over 16 undergoing oesophagectomy for oesophageal cancer.
What does the study involve?
Participants are given one of three doses of liquid vitamin D about 7 days before their oesophagectomy. We then measure their blood vitamin D levels after 7, 10 and 14 days.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Birmingham (UK).
When is the study starting and how long is it expected to run for?
November 2011 to June 2012.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Dr David Thickett
d.thickett@bham.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr David Thickett
ORCID ID
Contact details
Centre for Translational Inflammation Research
School of Clinical and Experimental Medicine
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
d.thickett@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0 19-08-2011
Study information
Scientific title
A phase II open label dosing study to optimise vitamin D levels prior to oesophagectomy
Acronym
VINDALOO
Study hypothesis
Developing vitamin D therapy to prevent acute respiratory distress syndrome following oesophagectomy. To study the optimal dose of vitamin D to be give preoperatively in patients undergoing oesophagectomy.
Ethics approval
Approval pending as of 22/08/2011
Study design
Open-labelled sequential dose-escalation study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oesophageal cancer/acute lung injury/oesophagecetomy
Intervention
Patients will be given a single dose of oral Vigantol® liquid approximately 7 days preoperatively.
Doses will be 100,000 units, 200,000 units or 300,000 units of vitamin D.
Intervention type
Supplement
Phase
Phase II
Drug names
Vitamin D (Vigantol®)
Primary outcome measure
The dose of Vigantol® that successfully increases serum vitamin D levels above 75 nmol/l in all cases
Secondary outcome measures
1. Safety and tolerability data - blood biochemistry, medication related side effects
2. Plasma 25D3 levels at 7, 10 and 14 days post dose
3. Plasma LL-37 (a downstream vitamin D target) at baseline and on the day of operation
4. Change in Plasma 1, 25 D3 (the biologically active hormone) from baseline on the day of operation
Overall trial start date
01/11/2011
Overall trial end date
01/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre
2. Aged over 16 years on day of first dose of Investigational Medicinal Product (IMP)
3. Ability to give written informed consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant exclusion criteria
1. Known intolerance of vitamin D
2. Known sarcoidosis, hyperparathyroidism, or nephrolithiasis
3. Taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment
4. Baseline serum corrected calcium > 2.65 mmol/L
5. Undergoing haemodialysis
6. Pregnant or breastfeeding
7. Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy
8. Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP
9. Diagnosis of chronic obstructive pulmonary disease (COPD) with an forced expiratory volume in one second (FEV1) less than 50% predicted or resting oxygen saturations of less 92%
Recruitment start date
01/11/2011
Recruitment end date
01/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
resgoviras@lists.bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G1100196)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list