Condition category
Cancer
Date applied
03/11/2011
Date assigned
21/12/2011
Last edited
31/03/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Thickett

ORCID ID

Contact details

University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 472 1311 (ext: 8289)
d.thickett@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 1 3-3-2011

Study information

Scientific title

Vitamin D replacement to prevent acute lung injury following oesophagectomy - a randomised placebo controlled trial

Acronym

VINDALOO-2

Study hypothesis

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

Not provided at time of registration

Study design

Randomised placebo-controlled phase II study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

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

Oesphageal cancer, acute lung injury

Intervention

Oral vitamin D liquid (100,000 IU) versus identical placebo

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2012

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

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 COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%

Recruitment start date

01/04/2012

Recruitment end date

01/04/2014

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
+44 (0)121 414 3344
b.a.laverty@bham.ac.uk

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council UK (MRC) ref: G1100196

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782429

Publication citations

Additional files

Editorial Notes