scholarly journals High Dose Vitamin-D-substitution in patients with COVID-19: study protocol for a randomized, double blind, placebo controlled, multi-centre study- VitCov Trial

2021 ◽  
Author(s):  
Fabienne Jaun ◽  
Giorgia Lüthi-Corridori ◽  
Kristin Abig ◽  
Anja Makhdoomi ◽  
Philippe Haas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Case Series ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Double Blind ◽  
Multi Centre Study ◽  
Treatment As Usual ◽  
Centre Study ◽  
High Dose Vitamin

Abstract BackgroundThe Coronavirus disease 19 (Covid-19) pandemic has caused more than a million deaths and new treatments are urgently needed. Factors associated with a worse Covid-19 prognosis include old age (> 65 years), ethnicity, male sex, obesity and people with comorbidities such as hypertension, diabetes, cardiovascular disease, and respiratory diseases. Further, vitamin D deficiency has been reported to be a predictor of poor prognosis in patients with acute respiratory failure due to Covid-19. Vitamin D deficiency is a modifiable risk factor, which - according to a recent clinical case series – has the prospect of reducing hospital stay, intensive care and fatal outcomes. Vitamin D has potent immunomodulatory property sand its supplementation might improve important outcomes in critically ill and vitamin D deficient Covid-19 patients. Despite the evidence that supports an association between vitamin D deficiency and Covid-19 severity, there is uncertainty about the direct link. The aim of the trial is therefore to assess if high dose vitamin D supplementation has a therapeutic effect in vitamin D deficient patients with Covid-19.MethodsRandomized, placebo-controlled double blind, multi-centre study trial to compare a high single dose of vitamin D (140’000 IU) followed by treatment as usual (TAU) (VitD + TAU) with treatment as usual only (placebo + TAU) in patients with Covid-19 and vitamin D deficiency.DiscussionVitamin D substitution in patients with Covid-19 and vitamin D deficiency should be investigated for efficacy and safety. The objective of the study is to test the hypothesis that patients with vitamin D deficiency suffering from Covid-19 treated under standardized conditions in hospital will recover faster when additionally treated with high dose vitamin D supplementation. Latest studies suggest, that vitamin D supplementation in patients with Covid-19 is highly recommended to positively influence the course of the disease. With this randomised controlled trial, a contribution to new treatment guidelines shall be made.Trial registration: clinicaltrials.gov: NCT04525820 and SNCTP: 2020 − 01401

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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 oral vitamin D supplementation and mortality in people aged 65–84 years: the VIDAL cluster feasibility RCT of open versus double-blind individual randomisation

2020 ◽  
Vol 24 (10) ◽  
pp. 1-54 ◽  
Author(s):  
Christine Rake ◽  
Clare Gilham ◽  
Laurette Bukasa ◽  
Richard Ostler ◽  
Michelle Newton ◽  
...  
Keyword(s):  
Vitamin D ◽  
Treatment Compliance ◽  
Health Technology ◽  
Vitamin D Supplementation ◽  
High Dose ◽  
Open Label ◽  
Double Blind ◽  
E Mail ◽  
High Dose Vitamin

Background Randomised controlled trials demonstrating improved longevity are needed to justify high-dose vitamin D supplementation for older populations. Objectives To demonstrate the feasibility of a large trial (n ≈ 20,000) of high-dose vitamin D in people aged 65–84 years through general practitioner (GP) practices, and to cluster randomise participating practices between open-label and double-blind randomisation to compare effects on recruitment, compliance and contamination. Design Twenty GP practices were randomised in matched pairs between open-label and double-blind allocation. Within each practice, patients were individually randomised to vitamin D or control (i.e. no treatment or placebo). Participants were invited to attend their GP practice to provide a blood sample and complete a lifestyle questionnaire at recruitment and again at 2 years. Randomisation by telephone followed receipt of a serum corrected calcium assay confirming eligibility (< 2.65 nmol/l). Treatment compliance was reported by quarterly follow-up forms sent and returned by e-mail or post (participant choice). GP visits and infections were abstracted from GP records. Hospital attendances, cancer diagnoses and deaths were ascertained by linkage to Hospital Episode Statistics and national registration through NHS Digital. Setting GP practices in England. Participants Recruitment opened in October 2013 and closed in January 2015. A total of 1615 registered patients aged 65–84 years were randomised: 407 to vitamin D and 421 to no treatment in open practices; 395 to vitamin D and 392 to placebo in blind practices. Interventions There was a 24-month treatment period: 12 monthly doses (100,000 IU of vitamin D3 or placebo as 5 ml oily solution) were posted after randomisation and at 1 year (100,000 IU per month corresponds to 3300 IU per day). Reminders were sent monthly by e-mail, text message or post. Main outcome measures Recruitment, compliance, contamination and change in circulating 25-hydroxyvitamin D [25(OH)D] from baseline to 2 years. Results Participation rates (randomised/invited) were 15.0% in open practices and 13.4% in double-blind practices (p = 0.7). The proportion still taking study medication at 2 years was 91.2% in open practices and 89.2% in double-blind practices (p = 0.4). The proportion of control participants taking > 400 IU vitamin D per day at 2 years was 5.0% in open practices and 4.8% in double-blind practices. Mean serum 25(OH)D concentration was 51.5 nmol/l [95% confidence interval (CI) 50.2 to 52.8 nmol/l] with 82.6% of participants < 75 nmol/l at baseline. At 2 years, this increased to 109.6 nmol/l (95% CI 107.1 to 112.1 nmol/l) with 12.0% < 75 nmol/l in those allocated to vitamin D and was unaltered at 51.8 nmol/l (95% CI 49.8 to 53.8 nmol/l) in those allocated to no vitamin D (no treatment or placebo). Conclusions A trial could recruit 20,000 participants aged 65–84 years through 200 GP practices over 2 years. Approximately 80% would be expected to adhere to allocated treatment (vitamin D or placebo) for 5 years. The trial could be conducted entirely by e-mail in participants aged < 80 years, but some participants aged 80–84 years would require postal follow-up. Recruitment and treatment compliance would be similar and contamination (self-administration of vitamin D) would be minimal, whether control participants are randomised openly to no treatment with no contact during the trial or randomised double-blind to placebo with monthly reminders. Trial registration Current Controlled Trials ISRCTN46328341 and EudraCT database 2011-003699-34. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 10. See the NIHR Journals Library website for further project information.

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