VItamiN D replacement to prevent Acute Lung injury following OesophagectOmy... | Not Recruiting
VItamiN D replacement to prevent Ac... | Not Recruiting
VItamiN D replacement to prevent Acute Lung injury following OesophagectOmy (VINDALOO-2)
VINDALOO-2

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Medical Conditions
  • Oesphageal cancer, acute lung injury
Primary Contact Details
Dr David Thickett
+44 (0)121 472 1311 (ext: 8289)
See all trial contact details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN27673620

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Summary
Not provided at time of registration
Research Details
  • 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
Phase
Sorry, this information is not available
Study Design
Randomised placebo-controlled phase II study
Study Type
Interventional
Intervention

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

Intervention Type
Supplement
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
Publication(s)
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782429
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
80
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 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%
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Dr David Thickett
+44 (0)121 472 1311 (ext: 8289)
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Vitamin D replacement to prevent acute lung injury following oesophagectomy - a randomised placebo controlled trial
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Medical Research Council UK (MRC) ref: G1100196
Other Study ID Numbers
version 1 3-3-2011
Sponsor(s)
University of Birmingham (UK)
Key Dates

Recruitment Start Date

01 Apr 2012

Recruitment End Date

01 Apr 2014

Trial Start Date

01 Apr 2012

Trial End Date

01 Apr 2014

Date added to source

21 Dec 2011

Date updated in source

31 Mar 2015