-
1.
Evaluation of Lactocare® Synbiotic Administration on the Serum Electrolytes and Trace Elements Levels in Psoriasis Patients: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial Study.
Akbarzadeh, A, Taheri, M, Ebrahimi, B, Alirezaei, P, Doosti-Irani, A, Soleimani, M, Nouri, F
Biological trace element research. 2022;200(10):4230-4237
-
-
-
Free full text
-
Plain language summary
Psoriasis is an immune-mediated chronic inflammatory skin disorder characterised by plaques and lesions on the skin. While the etiopathogenesis of psoriasis is not completely understood, various mechanisms have been implicated, including changes in the composition of intestinal microbes, oxidative stress and changes in the levels of certain trace elements. Previous research has shown that fluctuations in trace minerals such as zinc and copper may contribute to the progression and progression of psoriasis. It is known that synbiotics, which are combinations of probiotics and prebiotics, have immune-modulating properties, and they may also enhance the absorption of trace minerals from food when consumed. This double-blind, randomised, placebo-controlled trial was conducted to randomly assign sixty-four patients with mild-to-moderate psoriasis to consume Lactocare, a symbiotic containing seven strains of probiotic bacteria and prebiotic fructooligosaccharide twice daily or a placebo for 12 weeks. Serum trace mineral levels were measured after 12 weeks of treatment, including Fe, K, Ca, Mg, P, Zn, Na, and Cu. A significant improvement in serum levels of zinc and calcium was observed in the symbiotic group after 12 weeks of treatment. Additionally, the symbiotic treatment significantly increased the levels of trace minerals such as Fe, Ca, Mg, P, Zn, and Na within the group compared to the baseline. Fe and Cu levels in the treatment group were affected by sex, with male participants showing significant differences. To evaluate the other benefits of symbiotic preparations in patients with psoriasis, further large-scale studies are required. Healthcare professionals can utilise the research to understand the immune-modulating and anti-inflammatory properties of symbiotic formulations such as Lactocare, as well as to understand how the consumption of Lactocare improves the absorption of trace minerals.
Abstract
BACKGROUND Despite the exact etiopathogenesis of psoriasis remains unknown, the increasing or decreasing of some trace elements and oxidative stress status are considered to play a role. In this study, the effect of Lactocare® synbiotic on the serum levels of trace elements including Zn, Cu, Mg, Na, Fe, P, Ca, and K in the patients with mild to moderate psoriasis was investigated. METHODS Sixty-four patients with mild to moderate psoriasis were included. Patients were randomly divided into treatment (n═32) and control (n═32) groups. The treatment group received Lactocare® and the control group received a placebo (two times daily for 12 weeks). Eight patients from the intervention group and 18 patients from the control group discontinued the study because of the recent COVID-19 condition. For routine trace element analysis, the blood samples were collected from all patients at the baseline as well as week 12 post-treatment. The serum was then isolated and the serum levels of trace elements including Fe, K, Ca, Mg, P, Zn, Na, and Cu were measured using an automatic electrolyte analyzer. For confirmation of the effect of Lactocare® on the alteration of serum levels of trace elements, intra-group analysis was performed at two interval times: baseline and week 12 post-treatment. RESULTS The serum levels of K, P, and Ca in the placebo group were significantly higher than that of the treatment group at baseline. Serum levels of Zn and Ca were significantly higher in the treatment group compared to the placebo group at week 12 post-treatment. Moreover, a significantly lower serum level of K, P, and Ca in the treatment group at the baseline compared to the placebo group was compensated on week 12 post-treatment. Intra-group analysis in the treatment group showed that the serum levels of Fe, Ca, Mg, P, Zn, and Na was significantly increased at week 12 post-treatment compared to baseline levels. Whereas, intra-group analysis in the control group showed only Ca has a significant difference between baseline and week 12 post-treatment. CONCLUSION The serum levels of Fe, Zn, P, Mg, Ca, and Na are increased significantly 12 weeks after oral administration of Lactocare® in psoriatic patients. The serum level of Fe and Cu is affected by sex at pre- and post-treatment. This study supports the concept that Lactocare® exerts beneficial effects in the gastrointestinal tract to improve mineral absorption in psoriatic patients.
-
2.
Overweight and obesity as risk factors for COVID-19-associated hospitalisations and death: systematic review and meta-analysis.
Sawadogo, W, Tsegaye, M, Gizaw, A, Adera, T
BMJ nutrition, prevention & health. 2022;5(1):10-18
-
-
-
Free full text
Plain language summary
A novel coronavirus named SARS-CoV-2, causing COVID-19, emerged in late 2019. The prognosis of COVID-19 has been consistently reported to worsen with older age, male sex and comorbidities. The aim of this study was to quantify the association between overweight or obesity and COVID-19-related hospitalisations and death, and to assess the magnitude of the association and the potential dose–response relationships. This study is a systematic review and meta-analysis of 208 studies. A total of 3 550 977 participants from over 32 countries were included in this study. Results indicate that being overweight increases the risk of COVID-19-related hospitalisations but not death while obesity and extreme obesity increase the risk of both COVID-19-related hospitalisations and death. In addition, there was a linear dose–response association between obesity categories and COVID-19 outcomes. However, the strength of the association has weakened over time following the pattern of the first wave of COVID-19. Authors conclude that their findings suggest the importance of increased vigilance towards people with excess adiposity. Some preventative measures for this vulnerable group include prompt access to COVID-19 testing and healthcare, as well as prioritisation for COVID-19 vaccination.
Abstract
Objective: To quantify the current weight of evidence of the association between overweight and obesity as risk factors for COVID-19-related hospitalisations (including hospital admission, intensive care unit admission, invasive mechanical ventilation) and death, and to assess the magnitude of the association and the potential dose-response relationships. Design: PubMed, Embase, Cochrane, Web of Sciences, WHO COVID-19 database and Google Scholar were used to identify articles published up to 20 July 2021. Peer-reviewed studies reporting adjusted estimates of the association between overweight or obesity and COVID-19 outcomes were included. Three authors reviewed the articles and agreed. The quality of eligible studies was assessed using the Newcastle-Ottawa Quality Assessment Scale. Random-effects meta-analysis was used to estimate the combined effects. Results: A total of 208 studies with 3 550 997 participants from over 32 countries were included in this meta-analysis. Being overweight was associated with an increased risk of COVID-19-related hospitalisations (OR 1.19, 95% CI 1.12 to 1.28, n=21 studies), but not death (OR 1.02, 95% CI 0.92 to 1.13, n=21). However, patients with obesity were at increased risk of both COVID-19-related hospitalisations (OR 1.72, 95% CI 1.62 to 1.84, n=58) and death (OR 1.25, 95% CI 1.19 to 1.32, n=77). Similarly, patients with extreme obesity were at increased risk of COVID-19-related hospitalisations (OR 2.53, 95% CI 1.67 to 3.84, n=12) and death (OR 2.06, 95% CI 1.76 to 3.00, n=19). There was a linear dose-response relationship between these obesity categories and COVID-19 outcomes, but the strength of the association has decreased over time. Conclusion: Being overweight increases the risk of COVID-19-related hospitalisations but not death, while obesity and extreme obesity increase the risk of both COVID-19-related hospitalisations and death. These findings suggest that prompt access to COVID-19 care, prioritisation for COVID-19 vaccination and other preventive measures are warranted for this vulnerable group.
-
3.
Evidence for the Efficacy of a High Dose of Vitamin D on the Hyperinflammation State in Moderate-to-Severe COVID-19 Patients: A Randomized Clinical Trial.
Sarhan, N, Abou Warda, AE, Sarhan, RM, Boshra, MS, Mostafa-Hedeab, G, ALruwaili, BF, Ibrahim, HSG, Schaalan, MF, Fathy, S
Medicina (Kaunas, Lithuania). 2022;58(10)
-
-
-
Free full text
Plain language summary
Vitamin D insufficiency is an example of the factors which may affect snowballed COVID-19 risk and mortality. The aim of this study was to determine whether the clinical results and prognoses of COVID-19 patients are enhanced by supplementing a high dose of vitamin D relative to the conventional low dose. This study is a randomised controlled trial of 116 patients. Participants were randomly assigned to one of the two groups i.e. 58 patients received treatment with low-dose vitamin D and 58 received treatment with high-dose vitamin D. Results show that the incidence of mechanical ventilation, intensive care unit hospitalisation, death, sepsis, and atrial fibrillation in the high-dosage vitamin D group was considerably reduced compared to the low-dosage vitamin D group. However, the need for high oxygen was significantly higher in the high-dose vitamin D group compared to the low-dose group. Additionally, there was a significant difference in the monitored parameters before and after treatment in favour of the high-dose vitamin D group, which were significantly lower in the high-dose vitamin D group compared to the low-dose group. Authors conclude that the sooner micronutrients are administered to outpatients, the better the outcome, especially before supportive or specific treatment is commenced.
Abstract
Background and Objectives: Vitamin D supplementation plays a key effect in lowering cytokine storms among COVID-19 patients by influencing the activity of the renin-angiotensin system and the production of the angiotensin-2 converting enzyme. The study was conducted to explore the effect of high-dose intramuscular vitamin D in hospitalized adults infected with moderate-to-severe SARS-CoV-2 in comparison with the standard of care in the COVID-19 protocol. Materials and Methods: Two groups of patients were compared in this prospective randomized controlled trial as the vitamin D was administered orally to group 1 (alfacalcidol 1 mcg/day) and intramuscularly to group 2 (cholecalciferol 200,000 IU). One hundred and sixteen participants were recruited in total, with fifty-eight patients in each group. Following the Egyptian Ministry of Health's policy for COVID-19 management, all patients received the same treatment for a minimum of five days. Results: A significant difference was recorded in the length of hospital stay (8.6 versus 6.8 days), need for high oxygen or non-invasive mechanical ventilator (67% versus 33%), need for a mechanical ventilator (25% versus 75%), clinical improvement (45% versus 55%), the occurrence of sepsis (35% versus 65%), and in the monitored laboratory parameters in favor of high-dose vitamin D. Moreover, clinical improvement was significantly associated with the need for low/high oxygen, an invasive/non-invasive mechanical ventilator (MV/NIMV), and diabetes, while mortality was associated with the need for MV, ICU admission, atrial fibrillation, chronic obstructive pulmonary disease, asthma, and the occurrence of secondary infection. Conclusions: Our study showed that high-dose vitamin D was considered a promising treatment in the suppression of cytokine storms among COVID-19 patients and was associated with better clinical improvement and fewer adverse outcomes compared to low-dose vitamin D.
-
4.
Positive Effects of Vitamin D Supplementation in Patients Hospitalized for COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial.
De Niet, S, Trémège, M, Coffiner, M, Rousseau, AF, Calmes, D, Frix, AN, Gester, F, Delvaux, M, Dive, AF, Guglielmi, E, et al
Nutrients. 2022;14(15)
-
-
-
Free full text
Plain language summary
Literature shows that having enough vitamin D can help prevent many diseases, such as heart disease, bone disease and cancer. Recent data also showed that vitamin D can reduce the risk of respiratory tract infections, and particularly, the risk of viral infections. The aim of this study was to assess whether the proposed dosing regimen of a daily dose of 25,000 international units (IU) vitamin D administered over 4 consecutive days, followed by a weekly dose of 25,000 IU, was adequate to rapidly increase the concentrations of calcifediol in patients hospitalized with COVID-19 and to explore its impact on hospital length and other clinical outcomes of the disease. This study is an interventional, randomized, parallel, two-treatment, two-arm, double-blind and placebo-controlled pilot study, carried out in one clinical site in Belgium. The patients (n=50) were randomized in the two different treatment groups (vitamin D (n=26) or placebo (n=24)). Patients participated in the study for a maximum of 9 weeks, including an up to 6-week treatment period and a maximum of 3-week follow-up period. Results show that the study’s regimen was adequate to rapidly raise the calcifediol level above 20 ng/mL and improve the clinical outcome of patients requiring hospitalization for COVID-19. In fact, administration of cholecalciferol significantly reduced the hospital length of stay, reduced the duration of supplemental oxygen and improved the clinical status assessed by the World Health Organisation scale. Authors conclude that further studies with a larger number of patients are needed in order to further confirm their study’s findings.
Abstract
Retrospective studies showed a relationship between vitamin D status and COVID-19 severity and mortality, with an inverse relation between SARS-CoV-2 positivity and circulating calcifediol levels. The objective of this pilot study was to investigate the effect of vitamin D supplementation on the length of hospital stay and clinical improvement in patients with vitamin D deficiency hospitalized with COVID-19. The study was randomized, double blind and placebo controlled. A total of 50 subjects were enrolled and received, in addition to the best available COVID therapy, either vitamin D (25,000 IU per day over 4 consecutive days, followed by 25,000 IU per week up to 6 weeks) or placebo. The length of hospital stay decreased significantly in the vitamin D group compared to the placebo group (4 days vs. 8 days; p = 0.003). At Day 7, a significantly lower percentage of patients were still hospitalized in the vitamin D group compared to the placebo group (19% vs. 54%; p = 0.0161), and none of the patients treated with vitamin D were hospitalized after 21 days compared to 14% of the patients treated with placebo. Vitamin D significantly reduced the duration of supplemental oxygen among the patients who needed it (4 days vs. 7 days in the placebo group; p = 0.012) and significantly improved the clinical recovery of the patients, as assessed by the WHO scale (p = 0.0048). In conclusion, this study demonstrated that the clinical outcome of COVID-19 patients requiring hospitalization was improved by administration of vitamin D.
-
5.
Prognostic and Therapeutic Role of Vitamin D in COVID-19: Systematic Review and Meta-analysis.
Dissanayake, HA, de Silva, NL, Sumanatilleke, M, de Silva, SDN, Gamage, KKK, Dematapitiya, C, Kuruppu, DC, Ranasinghe, P, Pathmanathan, S, Katulanda, P
The Journal of clinical endocrinology and metabolism. 2022;107(5):1484-1502
-
-
-
Free full text
-
Plain language summary
Vitamin D is implicated in optimum function of the immune system. Its deficiency has been linked to susceptibility to respiratory infections. It is postulated that vitamin D deficiency/insufficiency is also associated with COVID-19. The aim of this study was to determine the association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, its severity, mortality and role of vitamin D in its treatment. This study is a systematic review and meta-analysis of seventy-six publications. Results show increased odds of developing COVID-19, progression to severe COVID-19 and death in people with vitamin D deficiency/insufficiency. In fact, people who developed COVID-19, severe COVID-19 and fatal disease had lower 25-hydroxy vitamin D concentration compared to people without COVID-19 or non-severe COVID-19 or non-fatal COVID-19 respectively. Authors conclude that Vitamin D deficiency/insufficiency may increase the risk of developing COVID-19 infection and susceptibility to more severe disease.
Abstract
PURPOSE Vitamin D deficiency/insufficiency may increase the susceptibility to coronavirus disease 2019 (COVID-19). We aimed to determine the association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, its severity, mortality, and role of vitamin D in its treatment. METHODS We searched CINAHL, Cochrane library, EMBASE, PubMED, Scopus, and Web of Science up to May 30, 2021, for observational studies on association between vitamin D deficiency/insufficiency and susceptibility to COVID-19, severe disease, and death among adults, and, randomized controlled trials (RCTs) comparing vitamin D treatment against standard care or placebo, in improving severity or mortality among adults with COVID-19. Risk of bias was assessed using Newcastle-Ottawa scale for observational studies and AUB-KQ1 Cochrane tool for RCTs. Study-level data were analyzed using RevMan 5.3 and R (v4.1.0). Heterogeneity was determined by I2 and sources were explored through prespecified sensitivity analyses, subgroup analyses, and meta-regressions. RESULTS Of 1877 search results, 76 studies satisfying eligibility criteria were included. Seventy-two observational studies were included in the meta-analysis (n = 1 976 099). Vitamin D deficiency/insufficiency increased the odds of developing COVID-19 (odds ratio [OR] 1.46; 95% CI, 1.28-1.65; P < 0.0001; I2 = 92%), severe disease (OR 1.90; 95% CI, 1.52-2.38; P < 0.0001; I2 = 81%), and death (OR 2.07; 95% CI, 1.28-3.35; P = 0.003; I2 = 73%). The 25-hydroxy vitamin D concentrations were lower in individuals with COVID-19 compared with controls (mean difference [MD] -3.85 ng/mL; 95% CI, -5.44 to -2.26; P ≤ 0.0001), in patients with severe COVID-19 compared with controls with nonsevere COVID-19 (MD -4.84 ng/mL; 95% CI, -7.32 to -2.35; P = 0.0001) and in nonsurvivors compared with survivors (MD -4.80 ng/mL; 95% CI, -7.89 to -1.71; P = 0.002). The association between vitamin D deficiency/insufficiency and death was insignificant when studies with high risk of bias or studies reporting unadjusted effect estimates were excluded. Risk of bias and heterogeneity were high across all analyses. Discrepancies in timing of vitamin D testing, definitions of severe COVID-19, and vitamin D deficiency/insufficiency partly explained the heterogeneity. Four RCTs were widely heterogeneous precluding meta-analysis. CONCLUSION Multiple observational studies involving nearly 2 million adults suggest vitamin D deficiency/insufficiency increases susceptibility to COVID-19 and severe COVID-19, although with a high risk of bias and heterogeneity. Association with mortality was less robust. Heterogeneity in RCTs precluded their meta-analysis.
-
6.
Effects of Vitamin D Serum Level on Morbidity and Mortality in Patients with COVID-19: A Systematic Review and Meta-Analysis.
Hu, Y, Kung, J, Cave, A, Banh, HL
Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques. 2022;25:84-92
-
-
-
Free full text
Plain language summary
COVID-19 caused by SARS-CoV-2 infection is associated with severe acute respiratory syndrome resulting from the excessive inflammatory response at 5-7 days. It has been shown that low Vitamin D serum concentration is associated with increased pneumonia and viral respiratory infections. The aim of this study was to determine the clinical effects of Vitamin D serum concentration in COVID-19 patients. This study is a systematic review and meta-analysis of 20 studies. Results show that Vitamin D serum concentration was not statistically associated with mortality and ICU admission, ventilator support requirement, and length of hospital stay. Authors conclude that additional randomized controlled trials are required to provide a specific supplemental vitamin dose and Vitamin D serum concentration.
Abstract
PURPOSE It has been shown that low Vitamin D serum concentration is associated with increased pneumonia and viral respiratory infections. Vitamin D is readily available, inexpensive, and easy to administer to subjects infected with COVID-19. If effective in reducing the severity of COVID-19, it could be an important and feasible therapeutic intervention. METHODS We performed a systematic review and meta-analysis of the literature to determine the effects of Vitamin D serum concentration on mortality and morbidity in COVID-19 patients. The primary objectives were to determine if Vitamin D serum concentration decrease mortality, ICU admissions, ventilator support, and length of hospital stay in COVID-19 patients. RESULTS A total of 3572 publications were identified. Ultimately, 20 studies are included. A total of 12,806 patients aged between 42 to 81 years old were analyzed. The pooled estimated RR for mortality, ICU admission, ventilator support and length of hospital stay were 1.49 (95% CI: 1.34, 1.65), 0.87 (95% CI: 0.67, 1.14), 1.29 (95% CI: 0.79, 1.84), and 0.84 (95% CI -0.45, 2.13). CONCLUSION There is no statistical difference in mortality, ICU admission rate, ventilator support requirement, and length of hospital stay in COVID-19 patients with low and high Vitamin D serum concentration.
-
7.
Clinical applications of detecting IgG, IgM or IgA antibody for the diagnosis of COVID-19: A meta-analysis and systematic review.
Chen, M, Qin, R, Jiang, M, Yang, Z, Wen, W, Li, J
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. 2021;104:415-422
-
-
-
Free full text
-
Plain language summary
The rapidly spreading nature of COVID-19 has put an emphasis on the importance of fast diagnosis. Gold standard diagnosis is through reverse transcription polymerase chain reaction (RT-PCR) tests, which aims to detect the presence of COVID-19. However, challenges with collection techniques and when in the disease lifecycle these tests are taken, can affect their reliability, highlighting a need for alternative methods of testing. Other testing methods exist, which involve testing the body’s own immune response to the presence of COVID-19, however these may also have their limitations. This systematic review and meta-analysis aimed to determine the effectiveness of testing the body’s own immune reaction for the presence of COVID-19. The results showed that testing the body’s immune reaction was effective, however if the person being tested is at an early stage in the disease, then it may be misdiagnosed. This study could be used by healthcare professionals to understand that the use of any type of COVID-19 testing may have its limitations, and although a person may test negative, there is still a possibility that they have the infection if symptoms exist
Abstract
BACKGROUND The coronavirus disease 2019 (COVID-19) pandemic has had a devastating impact worldwide, and timely detection and quarantine of infected patients are critical to prevent spread of disease. Serological antibody testing is an important diagnostic method used increasingly in clinics, although its clinical application is still under investigation. METHODS A meta-analysis was conducted to compare the diagnostic performance of severe acute respiratory syndrome coronavirus-2 antibody tests in patients with COVID-19. The test results analysed included: (1) IgM-positive but IgG-negative (IgM+IgG-); (2) IgG-positive but IgM-negative (IgG+IgM-); (3) both IgM-positive and IgG-positive (IgM+IgG+); (4) IgM-positive without IgG information (IgM+IgG+/-); (5) IgG-positive without IgM information (IgG+IgM+/-); (6) either IgM-positive or IgG-positive (IgM+ or IgG+); and (7) IgA-positive (IgA+). RESULTS Sixty-eight studies were included. Pooled sensitivities for IgM+IgG-, IgG+IgM-, IgM+IgG+, IgM+IgG+/-, IgG+IgM+/-, and IgM+ or IgG+ were 6%, 7%, 53%, 68%, 73% and 79% respectively. Pooled specificities ranged from 98% to 100%. IgA+ had a pooled sensitivity of 78% but a relatively low specificity of 88%. Tests conducted 2 weeks after symptom onset showed better diagnostic accuracy than tests conducted earlier. Chemiluminescence immunoassay and detection of S protein as the antigen could offer more accurate diagnostic results. DISCUSSION These findings support the supplemental role of serological antibody tests in the diagnosis of COVID-19. However, their capacity to diagnose COVID-19 early in the disease course could be limited.
-
8.
No evidence that vitamin D is able to prevent or affect the severity of COVID-19 in individuals with European ancestry: a Mendelian randomisation study of open data.
Amin, HA, Drenos, F
BMJ nutrition, prevention & health. 2021;4(1):42-48
-
-
-
Free full text
Plain language summary
Vitamin D is commonly discussed in terms of bone health and calcium and phosphate homeostasis, however, evidence has started to emerge that it may also be involved in cancer, the cardiovascular system and inflammation. The aim of this study was to assess whether genetically increased vitamin D levels are associated with SARS-CoV-2 infection risk and COVID-19 severity. This study is based on data from genome-wide association studies for vitamin D levels, vitamin D deficiency and COVID-19 incidence and severity. Results show no evidence that vitamin D is causally related to COVID-19 outcomes and there is no evidence to suggest that current National Institute for Health and Care Excellence guidance should change to support the use of vitamin D supplementation against COVID-19. Authors conclude that their findings support the recent statement by the National Institute for Health and Care Excellence that the use of vitamin D supplementation to mitigate COVID-19 is not supported by the available data.
Abstract
BACKGROUND Upper respiratory tract infections are reportedly more frequent and more severe in individuals with lower vitamin D levels. Based on these findings, it has been suggested that vitamin D can prevent or reduce the severity of COVID-19. METHODS We used two-sample Mendelian randomisation (MR) to assess the causal effect of vitamin D levels on SARS-CoV-2 infection risk and COVID-19 severity using publicly available data. We also carried out a genome-wide association analysis (GWA) of vitamin D deficiency in the UK Biobank (UKB) and used these results and two-sample MR to assess the causal effect of vitamin D deficiency on SARS-CoV-2 infection risk and COVID-19 severity. RESULTS We found no evidence that vitamin D levels causally affect the risk of SARS-CoV-2 infection (ln(OR)=0.17 (95% CI -0.22 to 0.57, p=0.39)) nor did we find evidence that vitamin D levels causally affect COVID-19 severity (ln(OR)=0.36 (95% CI -0.89 to 1.61, p=0.57)). Based on our GWA analysis, we found that 17 independent variants are associated with vitamin D deficiency in the UKB. Using these variants as instruments for our two-sample MR analyses, we found no evidence that vitamin D deficiency causally affects the risk of SARS-CoV-2 infection (ln(OR)=-0.04 (95% CI -0.1 to 0.03, p=0.25)) nor did we find evidence that vitamin D deficiency causally affects COVID-19 severity (ln(OR)=-0.24 (95% CI -0.55 to 0.08, p=0.14)). CONCLUSIONS In conclusion, we found no evidence that vitamin D is protective against SARS-CoV-2 infection or COVID-19 severity. Our data support the recent statement by the National Institute for Health and Care Excellence that the use of vitamin D supplementation to mitigate COVID-19 is not supported by the available data.
-
9.
Vitamin D supplementation for the treatment of COVID-19: a living systematic review.
Stroehlein, JK, Wallqvist, J, Iannizzi, C, Mikolajewska, A, Metzendorf, MI, Benstoem, C, Meybohm, P, Becker, M, Skoetz, N, Stegemann, M, et al
The Cochrane database of systematic reviews. 2021;5:CD015043
-
-
-
Free full text
-
Plain language summary
This study is part of a series of Cochrane Reviews investigating treatments and therapies for coronavirus disease 2019 (COVID-19). COVID-19 is a rapidly spreading infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therapeutic interventions to treat COVID-19 are being investigated with immense emphasis. Recently, vitamin D supplementation for treatment of COVID-19 gained attention, since studies suggested an association between vitamin D deficiency and risk or prognosis of the disease. The aim of this study was to assess whether vitamin D supplementation is effective and safe for the treatment of COVID-19 This study is a living systematic review of seven records (three randomised controlled studies – 356 adult participants). Results for the effectiveness of vitamin D supplementation for participants with COVID-19 are inconclusive. Moreover, inconsistency in the reporting of adverse and serious adverse events impeded evaluation of safety of vitamin D supplementation. Authors conclude that to elucidate the effectiveness and safety of vitamin D supplementation for individuals with COVID-19, more randomised controlled trials are needed.
Abstract
BACKGROUND The role of vitamin D supplementation as a treatment for COVID-19 has been a subject of considerable discussion. A thorough understanding of the current evidence regarding the effectiveness and safety of vitamin D supplementation for COVID-19 based on randomised controlled trials is required. OBJECTIVES To assess whether vitamin D supplementation is effective and safe for the treatment of COVID-19 in comparison to an active comparator, placebo, or standard of care alone, and to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS We searched the Cochrane COVID-19 Study Register, Web of Science and the WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 11 March 2021. SELECTION CRITERIA We followed standard Cochrane methodology. We included randomised controlled trials (RCTs) evaluating vitamin D supplementation for people with COVID-19, irrespective of disease severity, age, gender or ethnicity. We excluded studies investigating preventive effects, or studies including populations with other coronavirus diseases (severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS)). DATA COLLECTION AND ANALYSIS We followed standard Cochrane methodology. To assess bias in included studies, we used the Cochrane risk of bias tool (ROB 2) for RCTs. We rated the certainty of evidence using the GRADE approach for the following prioritised outcome categories: individuals with moderate or severe COVID-19: all-cause mortality, clinical status, quality of life, adverse events, serious adverse events, and for individuals with asymptomatic or mild disease: all-cause mortality, development of severe clinical COVID-19 symptoms, quality of life, adverse events, serious adverse events. MAIN RESULTS We identified three RCTs with 356 participants, of whom 183 received vitamin D. In accordance with the World Health Organization (WHO) clinical progression scale, two studies investigated participants with moderate or severe disease, and one study individuals with mild or asymptomatic disease. The control groups consisted of placebo treatment or standard of care alone. Effectiveness of vitamin D supplementation for people with COVID-19 and moderate to severe disease We included two studies with 313 participants. Due to substantial clinical and methodological diversity of both studies, we were not able to pool data. Vitamin D status was unknown in one study, whereas the other study reported data for vitamin D deficient participants. One study administered multiple doses of oral calcifediol at days 1, 3 and 7, whereas the other study gave a single high dose of oral cholecalciferol at baseline. We assessed one study with low risk of bias for effectiveness outcomes, and the other with some concerns about randomisation and selective reporting. All-cause mortality at hospital discharge (313 participants) We found two studies reporting data for this outcome. One study reported no deaths when treated with vitamin D out of 50 participants, compared to two deaths out of 26 participants in the control group (Risk ratio (RR) 0.11, 95% confidence interval (CI) 0.01 to 2.13). The other study reported nine deaths out of 119 individuals in the vitamin D group, whereas six participants out of 118 died in the placebo group (RR 1.49, 95% CI 0.55 to 4.04]. We are very uncertain whether vitamin D has an effect on all-cause mortality at hospital discharge (very low-certainty evidence). Clinical status assessed by the need for invasive mechanical ventilation (237 participants) We found one study reporting data for this outcome. Nine out of 119 participants needed invasive mechanical ventilation when treated with vitamin D, compared to 17 out of 118 participants in the placebo group (RR 0.52, 95% CI 0.24 to 1.13). Vitamin D supplementation may decrease need for invasive mechanical ventilation, but the evidence is uncertain (low-certainty evidence). Quality of life We did not find data for quality of life. Safety of vitamin D supplementation for people with COVID-19 and moderate to severe disease We did not include data from one study, because assessment of serious adverse events was not described and we are concerned that data might have been inconsistently measured. This study reported vomiting in one out of 119 participants immediately after vitamin D intake (RR 2.98, 95% CI 0.12 to 72.30). We are very uncertain whether vitamin D supplementation is associated with higher risk for adverse events (very low-certainty). Effectiveness and safety of vitamin D supplementation for people with COVID-19 and asymptomatic or mild disease We found one study including 40 individuals, which did not report our prioritised outcomes, but instead data for viral clearance, inflammatory markers, and vitamin D serum levels. The authors reported no events of hypercalcaemia, but recording and assessment of further adverse events remains unclear. Authors administered oral cholecalciferol in daily doses for at least 14 days, and continued with weekly doses if vitamin D blood levels were > 50 ng/mL. AUTHORS' CONCLUSIONS There is currently insufficient evidence to determine the benefits and harms of vitamin D supplementation as a treatment of COVID-19. The evidence for the effectiveness of vitamin D supplementation for the treatment of COVID-19 is very uncertain. Moreover, we found only limited safety information, and were concerned about consistency in measurement and recording of these outcomes. There was substantial clinical and methodological heterogeneity of included studies, mainly because of different supplementation strategies, formulations, vitamin D status of participants, and reported outcomes. There is an urgent need for well-designed and adequately powered randomised controlled trials (RCTs) with an appropriate randomisation procedure, comparability of study arms and preferably double-blinding. We identified 21 ongoing and three completed studies without published results, which indicates that these needs will be addressed and that our findings are subject to change in the future. Due to the living approach of this work, we will update the review periodically.
-
10.
Modest effects of dietary supplements during the COVID-19 pandemic: insights from 445 850 users of the COVID-19 Symptom Study app.
Louca, P, Murray, B, Klaser, K, Graham, MS, Mazidi, M, Leeming, ER, Thompson, E, Bowyer, R, Drew, DA, Nguyen, LH, et al
BMJ nutrition, prevention & health. 2021;4(1):149-157
-
-
-
Free full text
Plain language summary
A number of micronutrients, including vitamins C and D and zinc, have been shown to play key roles in supporting immune function and in reducing risk of respiratory infection. The aim of this study was to investigate whether users of the COVID-19 Symptom Study app who regularly took dietary supplements were less likely to test positive for SARS-CoV-2 infection. This study is an observational study on SARS-CoV-2 infection and dietary supplement use to date on over 400000 app users from three different countries. Results show a significant association between users of omega-3 fatty acid, probiotic, multivitamin or vitamin D supplements and lower risk of testing positive for infection with SARS-CoV-2 (particularly female users in the largest UK cohort). However, no effects were observed when taking zinc, vitamin C or garlic. Authors conclude that further studies testing the protective effects of specific supplements, and also possible adverse effects, on disease severity are required before any evidence-based recommendations can be made.
Abstract
OBJECTIVES Dietary supplements may ameliorate SARS-CoV-2 infection, although scientific evidence to support such a role is lacking. We investigated whether users of the COVID-19 Symptom Study app who regularly took dietary supplements were less likely to test positive for SARS-CoV-2 infection. DESIGN App-based community survey. SETTING 445 850 subscribers of an app that was launched to enable self-reported information related to SARS-CoV-2 infection for use in the general population in the UK (n=372 720), the USA (n=45 757) and Sweden (n=27 373). MAIN EXPOSURE Self-reported regular dietary supplement usage (constant use during previous 3 months) in the first waves of the pandemic up to 31 July 2020. MAIN OUTCOME MEASURES SARS-CoV-2 infection confirmed by viral RNA reverse transcriptase PCR test or serology test before 31 July 2020. RESULTS In 372 720 UK participants (175 652 supplement users and 197 068 non-users), those taking probiotics, omega-3 fatty acids, multivitamins or vitamin D had a lower risk of SARS-CoV-2 infection by 14% (95% CI (8% to 19%)), 12% (95% CI (8% to 16%)), 13% (95% CI (10% to 16%)) and 9% (95% CI (6% to 12%)), respectively, after adjusting for potential confounders. No effect was observed for those taking vitamin C, zinc or garlic supplements. On stratification by sex, age and body mass index (BMI), the protective associations in individuals taking probiotics, omega-3 fatty acids, multivitamins and vitamin D were observed in females across all ages and BMI groups, but were not seen in men. The same overall pattern of association was observed in both the US and Swedish cohorts. CONCLUSION In women, we observed a modest but significant association between use of probiotics, omega-3 fatty acid, multivitamin or vitamin D supplements and lower risk of testing positive for SARS-CoV-2. We found no clear benefits for men nor any effect of vitamin C, garlic or zinc. Randomised controlled trials are required to confirm these observational findings before any therapeutic recommendations can be made.