Condition category
Cancer
Date applied
19/08/2011
Date assigned
26/09/2011
Last edited
10/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.birmingham.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G1100196)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes