Impact of high-dose vitamin d supplementation on short physical performance battery and bioelectrical impedance analysis in older patients with prostate cancer on ADT.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23106-e23106 ◽  
Author(s):  
Julia Ellen Inglis ◽  
Eva Culakova ◽  
Richard Francis Dunne ◽  
Michelle Christine Janelsins ◽  
Po-Ju Lin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Vitamin D ◽  
Phase Angle ◽  
Older Patients ◽  
Low Dose ◽  
Bioelectrical Impedance ◽  
Impedance Analysis ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
High Dose Vitamin

e23106 Background: Androgen deprivation therapy (ADT) is standard treatment for prostate cancer but may cause changes in body composition that lead to decreased physical function. Low vitamin D status is also associated with decreased functionality. The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating functionality. The bioelectrical impedance analysis (BIA) is a portable tool for assessing lean mass and phase angle, a measure of nutrition status and frailty in chronic disease. Methods: This was a secondary analysis of a randomized controlled trial to assess the impact of high dose vitamin D in older patients (≥60 yrs) with prostate cancer on ADT. Patients with prostate cancer (N = 59, age 67.6 ± 5.4) with vitamin D insufficiency ( < 32 ng/ml) were randomized to high-dose vitamin D (n = 29, 600 IU/daily plus 50,000 IU/weekly) or low-dose vitamin D (n = 30, 600 IU/daily plus placebo weekly) for 24 weeks. SPPB tests and BIA were assessed at baseline, 12 weeks and 24 weeks. Phase angle values were calculated using atan(reactance/resistance) x (180°/π). A phase angle value < 5.7° is a valid cutoff for frailty in older men. Results: Serum analyses showed compliance with vitamin D intake (25-OH vitamin D change: high vitamin D = +32.0 ng/ml vs low dose RDA vitamin D = +4.3 ng/ml; p < .01). There were no difference at all three assessments for SPPB or lean mass between arms. The high-dose vitamin D group had wider phase angle values at 12 weeks (5.81º vs. 5.32º; p = .018) and 24 weeks (5.89º vs. 5.40º; p = .030). The low-dose group had phase angle values < 5.7º over the course of the study. At baseline, over 18% of patients had phase angle values below the 10th percentile of the general population matched on age and BMI. As vitamin D levels increased throughout the study, fewer patients fell below the 10th percentile. Conclusions: The high-dose vitamin D group maintained wider phase angle values over 24 weeks, while phase angle for the low-dose group decreased from baseline. High-dose vitamin D supplementation may impact factors related to phase angle and frailty in patients receiving ADT. Funding: NCI UGCA189961, R21CA175793, K07CA168911, and GR501293.

scholarly journals Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT

2020 ◽  
pp. 1-8
Author(s):  
Julia E. Inglis ◽  
Isabel D. Fernandez ◽  
Edwin van Wijngaarden ◽  
Eva Culakova ◽  
Jennifer E. Reschke ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Vitamin D ◽  
Physical Function ◽  
Phase Angle ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
High Dose Vitamin

scholarly journals High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Amanda Zaleski ◽  
Gregory Panza ◽  
Heather Swales ◽  
Pankaj Arora ◽  
Christopher Newton-Cheh ◽  
...  
Keyword(s):  
Vitamin D ◽  
Arterial Stiffness ◽  
Pulse Wave Velocity ◽  
Vitamin D Deficiency ◽  
Wave Velocity ◽  
Low Dose ◽  
Pulse Wave ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
High Dose Vitamin

Introduction. Vitamin D deficiency is associated with the onset and progression of hypertension and cardiovascular disease (CVD). However, mechanisms underlying vitamin D deficiency-mediated increased risk of CVD remain unknown. We sought to examine the differential effect of high-dose versus low-dose vitamin D supplementation on markers of arterial stiffness among ~40 vitamin D deficient adults with prehypertension.Methods. Participants were randomized to high-dose (4000 IU/d) versus low-dose (400 IU/d) oral vitamin D3 for 6 months. 24 hr ambulatory blood pressure (BP), carotid-femoral pulse wave velocity, and pulse wave analyses were obtained at baseline and after 6 months of vitamin D supplementation.Results. There were no changes in resting BP or pulse wave velocity over 6 mo regardless of vitamin D dose (allp>0.202). High-dose vitamin D decreased augmentation index and pressure by 12.3 ± 5.3% (p=0.047) and 4.0 ± 1.5 mmHg (p=0.02), respectively. However, these decreases in arterial stiffness were not associated with increases in serum 25-hydroxyvitamin D over 6 mo (p=0.425).Conclusion. High-dose vitamin D supplementation appears to lower surrogate measures of arterial stiffness but not indices of central pulse wave velocity.Clinical Trial Registration. This trial is registered with www.clinicaltrials.gov (Unique Identifier:NCT01240512).

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.

scholarly journals COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Cédric Annweiler ◽  
◽  
Mélinda Beaudenon ◽  
Jennifer Gautier ◽  
Romain Simon ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
High Risk ◽  
Older Patients ◽  
Standard Dose ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Randomized Controlled ◽  
High Dose Vitamin

Abstract Background With the lack of effective therapy, chemoprevention, and vaccination against SARS-CoV-2, focusing on the immediate repurposing of existing drugs gives hope of curbing the COVID-19 pandemic. A recent unbiased genomics-guided tracing of the SARS-CoV-2 targets in human cells identified vitamin D among the three top-scoring molecules manifesting potential infection mitigation patterns. Growing pre-clinical and epidemiological observational data support this assumption. We hypothesized that vitamin D supplementation may improve the prognosis of COVID-19. The aim of this trial is to compare the effect of a single oral high dose of cholecalciferol versus a single oral standard dose on all-cause 14-day mortality rate in COVID-19 older adults at higher risk of worsening. Methods The COVIT-TRIAL study is an open-label, multicenter, randomized controlled superiority trial. Patients aged ≥ 65 years with COVID-19 (diagnosed within the preceding 3 days with RT-PCR and/or chest CT scan) and at least one worsening risk factor at the time of inclusion (i.e., age ≥ 75 years, or SpO2 ≤ 94% in room air, or PaO2/FiO2 ≤ 300 mmHg), having no contraindications to vitamin D supplementation, and having received no vitamin D supplementation > 800 IU/day during the preceding month are recruited. Participants are randomized either to high-dose cholecalciferol (two 200,000 IU drinking vials at once on the day of inclusion) or to standard-dose cholecalciferol (one 50,000 IU drinking vial on the day of inclusion). Two hundred sixty participants are recruited and followed up for 28 days. The primary outcome measure is all-cause mortality within 14 days of inclusion. Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale for COVID-19, and the between-group comparison of safety. These outcomes are assessed at baseline, day 14, and day 28, together with the serum concentrations of 25(OH)D, creatinine, calcium, and albumin at baseline and day 7. Discussion COVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments. Trial registration ClinicalTrials.govNCT04344041. Registered on 14 April 2020 Trial status Recruiting. Recruitment is expected to be completed in April 2021.

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