VItamiN D replacement to prevent Acute Lung injury following OesophagectOmy (VINDALOO-2)
| ISRCTN | ISRCTN27673620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27673620 |
| Protocol serial number | version 1 3-3-2011 |
| Sponsor | University of Birmingham (UK) |
| Funder | Medical Research Council UK (MRC) ref: G1100196 |
- 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
Scientific
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 472 1311 (ext: 8289) |
|---|---|
| d.thickett@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo-controlled phase II study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Extravascular lung water index (EVLWI) at the end of oesophagectomy |
| Key secondary outcome measure(s) |
Clinical markers indicative of lung injury: |
| Completion date | 01/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2018 | Yes | No | |
| Protocol article | protocol | 17/04/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/10/2018: Publication reference added.
