None listed
Conditions
Brief summary
The primary purpose of the study is to determine whether providing a single high dose of vitamin D using in conjunction with standard treatment (including antibiotics) improves outcomes in adults hospitalised with pneumonia. The main hypothesis is that outcomes will be improved in those taking vitamin D compared to those who are given a placebo.
Interventions
Vitamin D3, 200,000 IU as a single dose orally.
Administration will be directly observed.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) A confirmed radiological diagnosis of pneumonia, defined as: ‘New inflammatory infiltrate on a chest radiograph where patients have an acute illness with clinical features of pneumonia and radiographic pulmonary shadowing that is at least segmental or present in one lobe and is neither pre-existing or because of some other known cause.’ (2) <48 hours since admission to hospital (3) Age >=18 years (4) Ability to give informed consent (5) Ability to orally consume the study medication (6) Ability to attend a follow-up appointment at 6 weeks post-study treatment for a chest x-ray
Exclusion criteria
(1) Pneumonia is not the principal reason for admission (2) Pneumonia associated with bronchial obstruction, bronchiectasis, or known tuberculosis (3) Use of vitamin D3 supplements other than as part of a multivitamin preparation where the daily intake would not exceed 400 IU. (4) High plasma corrected calcium > 2.6 mmol/L (corrected for plasma albumin concentration) (5) Use of immunosuppressants (e.g. doses of prednisone >10mg, methotrexate, azathioprine and cyclosporin) (6) Any prior history of hypercalcaemia, nephrolithiasis or sarcoidosis (7) Current kidney disorders requiring dialysis treatment or polycystic kidney disease (8) Cirrhosis of the liver (9) Already enrolled or planning to enrol in a research study that would conflict with full participation in the study or confound the observation or interpretation of the study findings (e.g. where vitamin D levels are tested and results are known by the participant; where the participant is required to take conflicting medications) (10) Pregnancy or breast-feeding.
Outcome results
None listed