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A dosing study to optimise vitamin D levels prior to oesophagectomy

Phase 2
Completed
Conditions
Oesophageal cancer/acute lung injury/oesophagecetomy
Cancer
Malignant neoplasm of oesophagus
Registration Number
ISRCTN66719785
Lead Sponsor
niversity of Birmingham (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
18
Inclusion Criteria

1. Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre
2. Aged over 16 years on day of first dose of Investigational Medicinal Product (IMP)
3. Ability to give written informed consent to participate in the study

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 chronic obstructive pulmonary disease (COPD) with an forced expiratory volume in one second (FEV1) less than 50% predicted or resting oxygen saturations of less 92%

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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