what dose of vitamin D is the right one trial

Phase 1

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

• Registration Number: EUCTR2011-004199-12-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

• Planned transthoracic oesophagectomy for oesophageal carcinoma at a participating centre. • Aged over 16 years on day of first dose of IMP • 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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 • baseline serum corrected calcium >2.65 mmol/L • undergoing haemodialysis • Pregnant or breastfeeding. • Taking cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy. • Taking oral preparation containing > 10 micrograms vitamin D/day up to 2 months before first dose of IMP. • 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