scholarly journals Effect of a Single, Oral, High-dose Vitamin D Supplementation on Endothelial Function in Patients with Peripheral Arterial Disease: A Randomised Controlled Pilot Study

2012 ◽  
Vol 44 (3) ◽  
pp. 307-312 ◽  
Author(s):  
H. Stricker ◽  
F. Tosi Bianda ◽  
S. Guidicelli-Nicolosi ◽  
C. Limoni ◽  
G. Colucci
Keyword(s):  
Vitamin D ◽  
Pilot Study ◽  
Peripheral Arterial Disease ◽  
Endothelial Function ◽  
Arterial Disease ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Peripheral Arterial ◽  
Randomised Controlled ◽  
High Dose Vitamin

scholarly journals High-dose vitamin D supplementation to prevent prostate cancer progression in localised cases with low-to-intermediate risk of progression on active surveillance (ProsD): protocol of a phase II randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044055
Author(s):  
Visalini Nair-Shalliker ◽  
David P Smith ◽  
Val Gebski ◽  
Manish I Patel ◽  
Mark Frydenberg ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Vitamin D ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Intermediate Risk ◽  
Risk Of Progression ◽  
Randomised Controlled ◽  
High Dose Vitamin

IntroductionActive surveillance (AS) for patients with prostate cancer (PC) with low risk of PC death is an alternative to radical treatment. A major drawback of AS is the uncertainty whether a patient truly has low risk PC based on biopsy alone. Multiparametric MRI scan together with biopsy, appears useful in separating patients who need curative therapy from those for whom AS may be safe. Two small clinical trials have shown short-term high-dose vitamin D supplementation may prevent PC progression. There is no substantial evidence for its long-term safety and efficacy, hence its use in the care of men with PC on AS needs assessment. This protocol describes the ProsD clinical trial which aims to determine if oral high-dose vitamin D supplementation taken monthly for 2 years can prevent PC progression in cases with low-to-intermediate risk of progression.Method and analysisThis is an Australian national multicentre, 2:1 double-blinded placebo-controlled phase II randomised controlled trial of monthly oral high-dose vitamin D supplementation (50 000 IU cholecalciferol), in men diagnosed with localised PC who have low-to-intermediate risk of disease progression and are being managed by AS. This trial will assess the feasibility, efficacy and safety of supplementing men with an initial oral loading dose of 500 000 IU cholecalciferol, followed by a monthly oral dose of 50 000 IU during the 24 months of AS. The primary trial outcome is the commencement of active therapy for clinical or non-clinical reason, within 2 years of AS.Ethics and disseminationThis trial is approved by Bellberry Ethics Committee (2016-06-459). All results will be reported in peer-reviewed journals.Trial registration numberACTRN12616001707459.

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