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 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 trial start date
01/04/2012
Overall trial end date
01/04/2014
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782429