a trial of vitamin d treatment to prevent lung damage following surgery for oesophagel cancer.

• Conditions: perioperative inflammation in patients undergoing oesophagectomy.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000332-25-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-28
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• • Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre. • Men aged over 18 years on day of first dose of IMP • Women over the age of 55 or more than 2 years since menopause. • Women of potential child bearing age (under 55 and less than 2 years since menopause) may be recruited provided they agree to use contraception during the pre- post operative period (8 weeks). • Ability to give written informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

• known intolerance of vitamin D. • known sarcoidosis, hyperparathyroidism, or nephrolithiasis. • taking more than 1000iu/day vitamin D supplementation in the month preceding enrolment. • known serum corrected calcium >2.65 mmol/L. • undergoing haemodialysis. • Pregnant or breastfeeding. • Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy. • Patients taking benzothiadiazine derivatives at doses higher than that which is recommended in the BNF • Patients taking benzothiadiazine derivative in combination with a calcium supplement • Patients with tuberculosis or lymphoma. • Individuals taking a dietary supplement containing > 1000 IU of vitamin D/day up to 1 months before first dose of IMP vitamin D will not be eligible to participate in the study and must not take additional supplements for the duration of the trial. • Diagnosis of COPD with an FEV1 less than 50% predicted or resting oxygen saturations of less 92%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified