scholarly journals Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 964 ◽  
Author(s):  
Olive Tang ◽  
Stephen Juraschek ◽  
Lawrence Appel

Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. There was substantial heterogeneity between trials, and no single trial incorporated all three key design features. Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls.

2020 ◽  
Vol 52 ◽  
pp. 102491
Author(s):  
Xiaojing Zhong ◽  
Ying Xiong ◽  
Dexian Wei ◽  
Shuhong Wang ◽  
Zhihui Xiao ◽  
...  

2017 ◽  
Vol 5 (12) ◽  
pp. 986-1004 ◽  
Author(s):  
Philippe Autier ◽  
Patrick Mullie ◽  
Alina Macacu ◽  
Miruna Dragomir ◽  
Magali Boniol ◽  
...  

PLoS ONE ◽  
2013 ◽  
Vol 8 (7) ◽  
pp. e69269 ◽  
Author(s):  
Francesca Sperati ◽  
Patrizia Vici ◽  
Marcello Maugeri-Saccà ◽  
Saverio Stranges ◽  
Nancy Santesso ◽  
...  

2018 ◽  
Vol 1 (21;1) ◽  
pp. 121-145 ◽  
Author(s):  
Joshua Robert Zadro

Background: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Current intervention strategies are failing to reduce the enormous global burden of LBP and are prompting researchers to investigate alternative management strategies, such as vitamin D supplementation. Vitamin D supplementation appears to down regulate pro-inflammatory cytokines which lead to pain and up regulate anti-inflammatory cytokines that reduce inflammation. These mechanisms might explain the increasing interest in the use of vitamin D supplementation for LBP. Objectives: To determine whether vitamin D supplementation improves pain more than a control intervention for individuals with LBP. Study Design: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Methods: We performed searches in numerous electronic databases combining key words relating to “vitamin D” and “LBP” until March 2017. Studies were included if they investigated vitamin D supplementation in participants with LBP, provided there was a comparison intervention. There was no restriction on the type of LBP, the intervention parameters investigated, or the type of clinical trial (e.g., randomized, non-randomized). Two reviewers independently performed the selection of studies, extracted data, rated the methodological quality of the included studies, and evaluated the overall quality of the evidence using the Grading of Recommendations Assessment, Delevopment, and Evaulation (GRADE) approach. Results: After screening 3,534 articles, 8 clinical trials were included in this systematic review. There is very low quality evidence (based on the GRADE approach) that vitamin D supplementation is not more effective than any intervention (including placebo, no intervention, and other conservative/ pharmacological interventions) (continuous pain measures [0–100]: mean difference [MD] = -2.65, 95% confidence interval [CI]: -10.42 to 5.12, P = 0.504, n = 5; self-reported reduction in pain: pooled odds ratio [OR] = 1.07, 95% CI: 0.35 to 3.26, P = 0.906, n = 5) or placebo/no intervention for individuals with LBP (continuous pain measures: MD = 1.29, 95% CI: -3.81 to 6.39, P = 0.620, n = 4; self-reported reduction in pain: pooled OR = 1.53, 95% CI: 0.38 to 6.20, P = 0.550, n = 4), where ‘n’ is the number of studies included in the meta-analysis. These results did not change when we stratified the meta-analyses by the type of vitamin supplementation (vitamin D3 vs. alfacalcidol) or the type of LBP (non-specific vs. LBP resulting from osteoporosis or vertebral fractures). Limitations: The overall quality of evidence was “very low” due to the poor methodological quality and small sample sizes of the included studies. Conclusions: Vitamin D supplementation is not more effective than placebo, no intervention, or other conservative/pharmacological interventions for LBP (based on very low quality evidence). These results are consistent, regardless of the type of LBP or vitamin D supplementation. Until well-designed and adequately powered clinical trials suggest otherwise, the prescription of vitamin D for LBP cannot be recommended. PROSPERO Registration No: CRD42016046874. www.crd.york.ac.uk/PROSPERO/display_record. asp?ID = CRD42016046874 Key words: Vitamin D, low back pain, chronic low back pain, alfacalcidol, osteoporosis, vertebral fractures, serum 25-hydroxyvitamin D, systematic review


2021 ◽  
Vol 19 (2) ◽  
pp. 83-90
Author(s):  
Ana C. Coelho-Oliveira ◽  
Bruno B. Monteiro-Oliveira ◽  
Rebeca B. M. Cavalcante ◽  
Daniel B. Santos ◽  
Anelise Sonza ◽  
...  

Objective: Consistent independent associations between lowserum 25-hydroxyvitamin D concentrations and susceptibilityto acute respiratory tract infections have suggested apossible involvement of vitamin D in reducing the risk ofrespiratory infections and proposing its replacement as apotential strategy for prevention or treatment in this context.However, the role of vitamin D supplementation in theinfection by the novel coronavirus named SARS-CoV-2 isstill under investigation and no clinical evidence has beenreported to date. Methods: Electronic searches in Pubmed,Embase and Scopus databases were conducted and threecohort studies that analyzed the effects of interaction ofvitamin D with COVID-19, published only in English, wereincluded. Two reviewers, which independently examinedtitles and abstracts, identified records through database searchand reference screening and irrelevant studies were excludedbased in eligibility criteria. Relevant full texts were analyzedfor eligibility, and all relevant studies were included in thesystematic review. Results: Three cohort studies were includedin this systematic review with a mean methodologicalquality low. Only one study demonstrated interaction of lowvitamin D concentration in patients with a positive diagnosisfor COVID-19. Randomized clinical trials and studies of goodmethodological quality are necessary to confirm the findingsof this systematic review. Conclusions: This systematic reviewhas not demonstrated consistent associations between lowlevels of vitamin D and susceptibility to COVID-19 infection.Further studies on vitamin D supplementation for the preventionof COVID-19 infection should be conducted..


Author(s):  
Nipith Charoenngam

Vitamin D plays an important role in maintaining healthy mineralized skeleton. It is also consid-ered an immunomodulatory agent that regulate the innate and adaptive immune systems. Multi-ple observational studies have demonstrated the association between low level of serum 25-hydroxyvitamin D [25(OH)D] and presence and severity of several rheumatic diseases, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), spondyloarthropathies and oste-oarthritis (OA). Nevertheless, the specific benefits of vitamin D supplement for treatment and prevention of rheumatic diseases are less accepted as the results from randomized clinical trials are inconsistent, although some conceivable benefits of vitamin D for improvement of disease ac-tivity of RA, SLE and OA have been demonstrated in meta-analyses. It is also possible that some individuals might benefit from vitamin D differently from others since inter-individual difference in responsiveness to vitamin D supplementation has been observed in genomic studies. Although the optimal level of serum 25(OH)D is still debatable, it is advisable it is advisable that patients with rheumatic diseases should maintain serum 25(OH)D level at least 30 ng/mL (75 nmol/L) to prevent osteomalacia, secondary osteoporosis and fracture, and possibly 40 – 60 ng/mL (100 – 150 nmol/L) to achieve maximal benefit from vitamin D for immune health and overall health.


2020 ◽  
Vol 39 (6) ◽  
pp. 1742-1752 ◽  
Author(s):  
Silvia Fogacci ◽  
Federica Fogacci ◽  
Maciej Banach ◽  
Erin D. Michos ◽  
Adrian V. Hernandez ◽  
...  

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0243768
Author(s):  
Liyuan Peng ◽  
Linjie Li ◽  
Peng Wang ◽  
Weelic Chong ◽  
Yin Li ◽  
...  

Background Observational studies suggest that low 25-hydroxyvitamin D status is common and has been associated with higher mortality in critically ill patients. This study aim to investigate whether vitamin D supplementation is associated with lower mortality in critically ill patients. Method We searched Medline, Embase, and Cochrane databases from inception to January 12, 2020, without language restrictions, for randomized controlled trials comparing the effect of vitamin D supplementation with placebo in critically ill patients. Two authors independently performed data extraction and assessed study quality. The primary outcome was all-cause mortality at the longest follow-up. Result We identified nine trials with a total of 2066 patients. Vitamin D supplementation was not associated with reduced all-cause mortality at the longest follow-up (RR 0.90, 95% CI 0.74 to 1.09, I2 = 20%), at 30 days (RR 0.81, 95% CI 0.56 to 1.15), at 90 days (RR 1.15, 95% CI 0.92 to 1.44), and at 180 days (RR 0.82, 95% CI 0.65 to 1.03). Results were similar in the sensitivity analysis. The sample size met the optimum size in trial sequential analysis. Similarly, supplemental vitamin D was not associated with length of ICU stay, hospital stay, or mechanical ventilation. Conclusion Vitamin D supplement was not associated with reduced all-cause mortality in critically ill patients. Systematic review registration Open Science Framework https://osf.io/bgsjq


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