A meta-analysis of randomized clinical trials on the impact of oral vitamin C supplementation on first-year outcomes in orthopedic patients.
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SUBMITTER: Hung KC
PROVIDER: S-EPMC8085077 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAntioxidant vitamin (vitamin E, beta-carotene, and vitamin C) are widely used for preventing major cardiovascular outcomes. However, the effect of antioxidant vitamin on cardiovascular events remains unclear.Methodology and principal findingsWe searched PubMed, EmBase, the Cochrane Central Register of Controlled Trials, and the proceedings of major conferences for relevant literature. Eligible studies were randomized controlled trials that reported on the effects of antioxidant vitamin on cardiovascular outcomes as compared to placebo. Outcomes analyzed were major cardiovascular events, myocardial infarction, stroke, cardiac death, total death, and any possible adverse events. We used the I(2) statistic to measure heterogeneity between trials and calculated risk estimates for cardiovascular outcomes with random-effect meta-analysis. Independent extraction was performed by two reviewers and consensus was reached. Of 293 identified studies, we included 15 trials reporting data on 188209 participants. These studies reported 12749 major cardiovascular events, 6699 myocardial infarction, 3749 strokes, 14122 total death, and 5980 cardiac deaths. Overall, antioxidant vitamin supplementation as compared to placebo had no effect on major cardiovascular events (RR, 1.00; 95%CI, 0.96-1.03), myocardial infarction (RR, 0.98; 95%CI, 0.92-1.04), stroke (RR, 0.99; 95%CI, 0.93-1.05), total death (RR, 1.03; 95%CI, 0.98-1.07), cardiac death (RR, 1.02; 95%CI, 0.97-1.07), revascularization (RR, 1.00; 95%CI, 0.95-1.05), total CHD (RR, 0.96; 95%CI, 0.87-1.05), angina (RR, 0.98; 95%CI, 0.90-1.07), and congestive heart failure (RR, 1.07; 95%CI, 0.96 to 1.19).Conclusion/significanceAntioxidant vitamin supplementation has no effect on the incidence of major cardiovascular events, myocardial infarction, stroke, total death, and cardiac death.
| S-EPMC3577664 | biostudies-literature
Project description:BackgroundTo evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) through a systematic review and meta-analysis of randomized control trials (RCTs).MethodsPubMed-Medline, SCOPUS, Google Scholar and Web of Science databases were searched (up until April 2016) to identify RCTs evaluating the impact of vitamin D supplementation on CRP. We used random effects models (using DerSimonian-Laird method) as well as the generic inverse variance methods for quantitative data synthesis. For sensitivity analysis, we applied leave-one-out approach. To examine the heterogeneity we used I2 index. Registration code: CRD42016036932.ResultsAmong 1274 search items, 24 studies met the inclusion criteria in the final evaluation. Pooling the data together indicated a non-significant decrease in CRP level following administration of vitamin D (weighted mean difference [WMD] -0.26(mg/l), (95% CI -0.75 to 0.22, N = 26 arms, heterogeneity p = 0.042; I2 54.2%). The WMDs for IL6 was 0.67 pg/ml, (95% CI 0.29 to 1.06, N = 16 arms, heterogeneity p = 0.234; I2 19.1%), 0.43 pg/ml, (95% CI 0.08 to 1.05, N = 26 arms, heterogeneity p = 0.120; I2 42.1%), for IL10, and -0.11 pg/ml, (95% CI -0.53 to 0.30, N = 12 arms, heterogeneity p = 0.423; I2 9.2%) for TNF-α, 4.03 pg/ml, (95% CI 3.50 to 4.57, N = 3 arms, heterogeneity p = 0.752; I2 8.1%) for adiponectin. Sensitivity analyses confirmed the robustness of the findings.ConclusionsThis study provided evidence that vitamin D supplementation had no impact on serum CRP, IL10, and TNF-α, while significantly increased serum IL6. We recommend RCTs with longer period of follow-up time (12 months) for future studies to provide explicit results.
| S-EPMC7050714 | biostudies-literature
Project description:This meta-analysis assessed the association between vitamin D supplementation and the outcomes of critically ill adult patients. A literature search was conducted using the PubMed, Web of Science, EBSCO, Cochrane Library, Ovid MEDLINE, and Embase databases until March 21, 2020. We only included randomized controlled trials (RCTs) comparing the efficacy of vitamin D supplementation with placebo in critically ill adult patients. The primary outcome was their 28-day mortality. Overall, 9 RCTs with 1867 patients were included. In the pooled analysis of the 9 RCTs, no significant difference was observed in 28-day mortality between the vitamin D supplementation and placebo groups (20.4% vs 21.7%, OR, 0.73; 95% CI, 0.46-1.15; I2 = 51%). This result did not change as per the method of vitamin D supplementation (enteral route only: 19.9% vs 18.2%, OR, 1.19; 95% CI, 0.88-1.57; I2 = 10%; intramuscular or intravenous injection route: 25.6% vs 40.8%, OR, 0.48; 95% CI, 0.21-1.06; I2 = 19%) or daily dose (high dose: 20.9% vs 19.8%, OR, 0.83; 95% CI, 0.51-1.36; I2 = 53%; low dose: 15.6% vs 21.3%, OR, 0.74; 95% CI, 0.32-1.68; I2 = 0%). No significant difference was observed between the vitamin D supplementation and placebo groups regarding the length of ICU stay (standard mean difference [SMD], - 0.30; 95% CI, - 0.61 to 0.01; I2 = 60%), length of hospital stay (SMD, - 0.17; 95% CI, - 041 to 0.08; I2 = 65%), and duration of mechanical ventilation (SMD, - 0.41; 95% CI, - 081 to 0.00; I2 = 72%). In conclusion, this meta-analysis suggested that the administration of vitamin D did not provide additional advantages over placebo for critically ill patients. However, additional studies are needed to confirm our findings.
| S-EPMC7459294 | biostudies-literature
Project description:BACKGROUND: B vitamins have been extensively used to reduce homocysteine levels; however, it remains uncertain whether B vitamins are associated with a reduced risk of stroke. Our aim was to evaluate the effects of B vitamins on stroke. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched PubMed, EmBase, and the Cochrane Central Register of Controlled Trials to identify studies for our analysis. Relative risk (RR) was used to measure the effect of B-vitamin supplementation on the risk of stroke. The analysis was further stratified based on factors that could affect the treatment effects. Of the 13,124 identified articles, we included 18 trials reporting data on 57,143 individuals and 2,555 stroke events. B-vitamin supplementation was not associated with a significant reduction in the risk of stroke (RR, 0.91, 95%CI: 0.82-1.01, P = 0.075; RD, -0.003, 95%CI: -0.007-0.001, P = 0.134). Subgroup analyses suggested that B-vitamin supplementation might reduce the risk of stroke if included trials had a man/woman ratio of more than 2 or subjects received dose of folic acid less than 1 mg. Furthermore, in a cumulative meta-analysis for stroke, the originally proposed nonsignificant B-vitamin effect was refuted by the evidence accumulated up to 2006. There is a small effect with borderline statistical significance based on data gathered since 2007. CONCLUSIONS/SIGNIFICANCE: Our study indicates that B-vitamin supplementation is not associated with a lower risk of stroke based on relative and absolute measures of association. Subgroup analyses suggested that B-vitamin supplementation can effectively reduce the risk of stroke if included trials had a man/woman ratio of more than 2 or subjects received dose of folic acid less than 1 mg.
| S-EPMC3839876 | biostudies-literature
Project description:BackgroundPrevious observational studies have supported the hypothesis that vitamin D supplementation protects against stroke. However, several current intervention studies contradict this observation. Therefore, we conducted a meta-analysis to investigate further the association between vitamin D supplementation and the risk of stroke.MethodsThis meta-analysis was conducted in accordance with the PRISMA statement and included all the randomized controlled trials (RCTs) that analyzed the relationship between vitamin D supplementation and the risk of stroke. A literature search strategy was established, and the following Medical Search Terms (MeSH) were used: "vitamin D," "Calcitriol," "Calcifediol," "Cholecalciferol," "25-Hydroxyvitamin D 2," "ergocalciferols," "stroke," and stroke-derived terms. We searched for articles published before January 2022 in several databases, namely, PubMed, Web of Science, EMBASE, and The Cochrane Library. We also reviewed references included in relevant published meta-analyses and searched the http://www.ClinicalTrials.gov website for additional RCTs. The Q test and I 2 were utilized to assess the degree of heterogeneity among the studies. Review Manager 5.3 and STATA16.0 software programs were used to assess the literature quality and perform statistical analyses.ResultsIn total, twenty-four RCTs (86,202 participants) were included. There was no statistical heterogeneity among the RCTs (I 2 = 0.0%, P = 0.94) included in this meta-analysis. We determined that vitamin D supplementation was not associated with a reduced risk of stroke compared with the placebo (RR = 1.02, 95% CI: 0.93-1.13, P = 0.65). In total, 10 studies only included women, and 14 studies included women and men among the 24 RCTs. Therefore, we performed a subgroup analysis based on sex. After the subgroup analysis, the effect remained statistically insignificant (mixed-sex group: RR = 1.06, 95% CI: 0.93-1.22, P = 0.37, women group: RR = 0.98, 95% CI: 0.86-1.13, P = 0.80). The results were generally comparable, based on age, body mass index (BMI), follow-up period, baseline 25-hydroxyvitamin D (25(OH)D) levels, the designated endpoint, latitude, vitamin D dosage, type of vitamin D administered, and an absence or presence of concurrent calcium supplementation (P > 0.05).ConclusionOur study revealed that additional vitamin D supplementation did not reduce the risk of stroke. Therefore, additional RCTs of similar design should not be encouraged to assess any association between vitamin D supplementation and reduced stroke risk.
| S-EPMC9434369 | biostudies-literature
Project description:Summary Vitamin D has many protective properties and potential role against acute lung injury. Low serum vitamin D is associated with high risk of pneumonia and development of acute respiratory distress syndrome. This study sought to analyse the efficacy of vitamin D in improving the outcomes of coronavirus disease 2019 (Covid‐19) patients. Using specific keywords, we comprehensively searched the potential articles on PubMed, Europe PMC and ClinicalTrials.gov database until 8th May 2021. All published studies on Covid‐19 and vitamin D were retrieved. Statistical analysis was conducted using Review Manager 5.4 software. A total of 11 studies with 22,265 Covid‐19 patients were included in the meta‐analysis. Our data suggested that vitamin D supplementation was associated with reduction in intensive care unit admission rate (OR 0.27; 95% CI: 0.09–0.76, p = 0.010, I2 = 70%, random‐effect modelling); reduction of the need for mechanical ventilation (OR 0.34; 95% CI: 0.16–0.72, p = 0.005, I2 = 61%, random‐effect modelling) and reduction of mortality from Covid‐19 (OR 0.37; 95% CI: 0.21–0.66, p < 0.001, I2 = 50%, random‐effect modelling). Further analysis showed that the associations were influenced by age (p = 0.020). Our study suggests that vitamin D supplementation may offer beneficial effects on Covid‐19 outcomes. However, more randomized clinical trials are required to confirm this conclusion.
| S-EPMC8420388 | biostudies-literature
Project description:Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34) and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.
| S-EPMC3989270 | biostudies-literature
Project description:Introduction: Discontinuation of oral anticoagulants such as non-vitamin K antagonist oral anticoagulants (NOACs) may induce a hypercoagulable state, leading to severe stroke and poor outcomes. This study aimed to compare stroke outcomes between NOACs withdrawal and other prior medication statuses in patients with non-valvular atrial fibrillation (NVAF). Methods: Consecutive patients who had pre-existing NVAF and were admitted for an acute ischemic stroke or transient ischemic attack- at five hospitals between January 2013 and December 2016 were included. Prior medication status was categorized into seven groups such as no antithrombotics, antiplatelet-only, warfarin with subtherapeutic intensity, warfarin with therapeutic intensity, NOAC, warfarin withdrawal, and NOAC withdrawal. We compared initial National Institute of Health Stroke Scale (NIHSS) scores between groups Results: Among 719 patients with NVAF, The median NIHSS score at admission was 5 (IQR 1-13). The NOAC withdrawal group had the highest median NIHSS scores at stroke onset [16, interquartile range, IQR (1-17)], followed by the warfarin withdrawal group [11, IQR (1-14, 18)], the no antithrombotic group [5, IQR (1-13, 18, 19)], and the warfarin with subtherapeutic intensity group [5, IQR (1-10, 18, 19)]. A Multivariable analysis demonstrated that NOAC withdrawal was independently associated with higher NIHSS scores at stroke onset (B 4.645, 95% confidence interval 0.384-8.906, P = 0.033). The median interval from drug withdrawal to ischemic stroke or TIA was 7 days (IQR 4-15) in the NOAC group. Conclusions: Stroke that occurred after stopping oral anticoagulants, especially NOAC, and was more severe at presentation and associated with poorer outcomes.
| S-EPMC6305496 | biostudies-literature
Project description:ObjectiveTo assess the safety and health effects of vitamin D supplementation during pregnancy.Methods and designDatasets from two randomized clinical trials were first analyzed separately then combined for this analysis using a common data dictionary. In the NICHD trial, women were randomized to 400, 2000, or 4000IU vitamin D3/day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000IU vitamin D3/day. Study drugs were from the same manufacturing lot for both trials. Identical questionnaires were given for comparable sociodemographics & clinical characteristics. Outcome measures were: [1] maternal and neonatal 25(OH)D achieved, and [2] maternal comorbidities of pregnancy (COP). SAS 9.3 was used for all analyses.ResultsIn the combined cohort, there were 110 controls, 201 in the 2000IU group, and 193 in the 4000IU group. No differences between groups in baseline 25(OH)D were found; however, delivery and cord blood values were greater in the 4000IU group (p<0.0001), an effect that persisted even after controlling for race and study. A greater percent were vitamin D replete in the 4000IU group (p<0.0001). There was a trend where the 4000IU group had decreased rates of comorbidities of pregnancy. There was a strong association between COP and final maternal 25(OH)D; an effect that persisted even after controlling for race and study (p=0.006).ConclusionsSupplementation with 4000IU/day was associated with lower risk of hypovitaminosis D than Control and 2000IU groups. While not statistically significant, there was a trend toward lower rates of COP as supplementation dose increased. Maternal delivery 25(OH)D was inversely associated with any comorbidity of pregnancy, with fewer events as 25(OH)D increased. Future studies are needed to confirm these findings and determine the mechanisms of action of such effects. This article is part of a Special Issue entitled 'Vitamin D Workshop'.
| S-EPMC4365419 | biostudies-literature
Project description:To study supplementation effect of vitamin K (VK) alone or combined with other nutrients administered to pregnant women, we searched Cochrane Pregnancy and Childbirth Group's Trials Register (till 22 January 2016, updated on 28 February 2018) including other resources. Two review authors independently assessed randomised or quasi-randomised controlled trials for inclusion, data extraction, accuracy, and risk of bias. We included older trials from high-income countries (six; 21,493 women-newborns), judged mostly as high or unclear bias risk. We could not assess high-risk e.g. epileptic women, but healthy women (different gestational ages) received varying VK dosages and duration. We meta-analysed neonatal bleeding (RR 1.16, 95% CI 0.59 to 2.29; P?=?0.67) and maternal plasma VK1 (MD 2.46, 95% CI 0.98 to 3.93; P?=?0.001). We found many outcomes were un-assessed e.g. perinatal death, maternal bleeding, healthcare utilization. Mostly newborns were included where VK found significantly effective for e.g. serum VK (mother-newborn), maternal breast milk VK. Few trials reported neonatal adverse side effects. The GRADE evidence quality was very low i.e. neonatal bleeding, neonatal jaundice, maternal plasma VK1. The intervention was favourable for maternal sera VK1 but remained uncertain for neonatal bleeding and other outcomes. The existing literature gaps warrant future investigations on un-assessed or inadequately reported outcomes.
| S-EPMC6065418 | biostudies-literature