EUCTR2011-004199-12-GBActive, not recruitingPhase 1
An open label dose ranging study to optimise vitamin D levels prior to oesophagectomy - vitamin d open label replacement oesophagectomy.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- niversity of Birmingham
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
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%.
Investigators
Similar Trials
Completed
Phase 2
A dosing study to optimise vitamin D levels prior to oesophagectomyCancerISRCTN66719785niversity of Birmingham (UK)18
Recruiting
Not Applicable
A phase 1b, dose finding, open label study of the safety and tolerability of carboplatin-cyclophosphamide combined with atezolizumab, an antibody that targets programmed death ligand 1 (PD-L1), in patients with advanced breast cancer, ovarian, cervical and endometrial cancer.breast cancerNL-OMON45572ederlands Kanker Instituut12
Active, not recruiting
Phase 1
Riociguat for treatment of PAH in children from 6 to less than 18 years oldPulmonary arterial hypertension (PAH)MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-003952-29-PLBayer AG24
Active, not recruiting
Phase 1
Riociguat for treatment of PAH in children from 6 to less than 18 years oldHypertension, PulmonaryEUCTR2014-003952-29-HUBayer AG24
Active, not recruiting
Phase 1
Riociguat for treatment of PAH in children from 6 to less than 18 years oldPulmonary arterial hypertension (PAH)MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2014-003952-29-BEBayer AG20