VItamiN D replacement to prevent Acute Lung injury following OesophagectOmy (VINDALOO-2)

ISRCTN	ISRCTN27673620
DOI	https://doi.org/10.1186/ISRCTN27673620
Secondary identifying numbers	version 1 3-3-2011

Submission date: 03/11/2011
Registration date: 21/12/2011
Last edited: 29/10/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Thickett
Scientific

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 472 1311 (ext: 8289)
Email	d.thickett@bham.ac.uk

Study information

Study design	Randomised placebo-controlled phase II study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
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	Vitamin D replacement to prevent acute lung injury following oesophagectomy - a randomised placebo controlled trial
Study acronym	VINDALOO-2
Study objectives	This is a randomised double-blind placebo-controlled study to test the safety and efficacy of rapid vitamin D replacement upon extravascular lung water and markers of alveolar/systemic inflammation in patients undergoing oesophagectomy. The pilot study was registered in September 2011: www.controlled-trials.com/ISRCTN66719785
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oesphageal cancer, acute lung injury
Intervention	Oral vitamin D liquid (100,000 IU) versus identical placebo
Intervention type	Supplement
Primary outcome measure	Extravascular lung water index (EVLWI) at the end of oesophagectomy
Secondary outcome measures	Clinical markers indicative of lung injury: 1. P:F ratio 2. Oxygenation index 3. Development of lung injury / ARDS day 0-28 4. Duration of ventilation and organ failure, survival 5. Safety and tolerability of vitamin D supplementation 6. Plasma indices of endothelial and alveolar epithelial function/ injury 7. Plasma inflammatory response 8. Plasma LL-37 levels 9. Plasma vitamin D status (25D3, 1,25D3 and VDBP) 10. EVLWI post-operative day 1
Overall study start date	01/04/2012
Completion date	01/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	80
Key inclusion criteria	1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre 2. Aged over 18 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 COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%
Date of first enrolment	01/04/2012
Date of final enrolment	01/04/2014

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

Phone	+44 (0)121 414 3344
Email	b.a.laverty@bham.ac.uk
Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council UK (MRC) ref: G1100196

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/04/2013		Yes	No
Results article	results	01/12/2018		Yes	No

Editorial Notes

29/10/2018: Publication reference added.