A dosing study to optimise vitamin D levels prior to oesophagectomy

ISRCTN	ISRCTN66719785
DOI	https://doi.org/10.1186/ISRCTN66719785
Secondary identifying numbers	Version 1.0 19-08-2011

Submission date: 19/08/2011
Registration date: 26/09/2011
Last edited: 29/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr David Thickett
Scientific

Centre for Translational Inflammation Research
School of Clinical and Experimental Medicine
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	d.thickett@bham.ac.uk

Study information

Study design	Open-labelled sequential dose-escalation study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A phase II open label dosing study to optimise vitamin D levels prior to oesophagectomy
Study acronym	VINDALOO
Study objectives	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(s)	Approval pending as of 22/08/2011
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2011
Completion date	01/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	18
Key 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
Key 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%
Date of first enrolment	01/11/2011
Date of final enrolment	01/06/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Email	resgoviras@lists.bham.ac.uk
Website	http://www.birmingham.ac.uk
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G1100196)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/01/2018: No publications found, verifying study status with principal investigator.