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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Efficacy of probiotic treatment as post-exposure prophylaxis for COVID-19: A double-blind, Placebo-Controlled Randomized trial.
Wischmeyer, PE, Tang, H, Ren, Y, Bohannon, L, Jiang, D, Bergens, M, Ramirez, ZE, Andermann, TM, Messina, JA, Sung, JA, et al
Clinical nutrition (Edinburgh, Scotland). 2024;43(1):259-267
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The Coronavirus Disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus infection, continues to pose a unique and novel challenge to global health. Ongoing research is showing a potentially significant role of the microbiome and dysbiosis in COVID-19 disease severity and development of Long-Covid. The aim of this study was to investigate the efficacy of the probiotic Lacticaseibacillus rhamnosus GG (LGG) as post-exposure prophylaxis against COVID-19. This study was a randomised, double-blind, placebo-controlled trial. Participants were randomised to receive LGG or placebo in a 1:1 ratio. Results showed that the participants randomised to LGG had fewer symptoms and prolonged time to development of COVID-19 compared to those receiving placebo. Additionally, probiotic supplementation also reduced symptomatic disease, and changed the gut microbiome structure. Authors conclude that their findings lend credence to the notion that symbiotic microbes may be valuable partners in the fight against COVID-19 and potentially other future pandemic diseases.
Abstract
BACKGROUND & AIMS The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, additional strategies to mitigate the spread/severity of COVID-19 continue to be needed. Emerging evidence suggests susceptibility to respiratory tract infections in healthy subjects can be reduced by probiotic interventions; thus, probiotics may be a low-risk, low-cost, and easily implementable modality to reduce risk of COVID-19. METHODS In this initial study, we conducted a randomized, double-blind, placebo-controlled trial across the United States testing probiotic Lacticaseibacillus rhamnosus GG (LGG) as postexposure prophylaxis for COVID-19 in 182 participants who had household exposure to someone with confirmed COVID-19 diagnosed within ≤7 days. Participants were randomized to receive oral LGG or placebo for 28 days. The primary outcome was development of illness symptoms within 28 days of COVID-19 exposure. Stool was collected to evaluate microbiome changes. RESULTS Intention-to-treat analysis showed LGG treatment led to a lower likelihood of developing illness symptoms versus placebo (26.4 % vs. 42.9 %, p = 0.02). Further, LGG was associated with a statistically significant reduction in COVID-19 diagnosis (log rank, p = 0.049) via time-to-event analysis. Overall incidence of COVID-19 diagnosis did not significantly differ between LGG and placebo groups (8.8 % vs. 15.4 %, p = 0.17). CONCLUSIONS This data suggests LGG is associated with prolonged time to COVID-19 infection, reduced incidence of illness symptoms, and gut microbiome changes when used as prophylaxis ≤7 days post-COVID-19 exposure, but not overall incidence. This initial work may inform future COVID-19 prevention studies worldwide, particularly in developing nations where Lacticaseibacillus probiotics have previously been utilized to reduce other non-COVID infectious-morbidity. TRIAL REGISTRATION ClinicalTrials.gov, NCT04399252, Date: 22/05/2020. https://clinicaltrials.gov/ct2/show/NCT04399252.
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Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.
Rotter, G, Teut, M, Schleicher, R, Dell'Oro, M, Ortiz, M, Binting, S, Tissen-Diabaté, T, Roll, S, Michalsen, A, Staab, D, et al
Journal of integrative and complementary medicine. 2023;29(2):99-110
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Relaxation techniques, diet, and exercise can diminish atopic dermatitis (AD) symptoms. Patients with AD worry about the side-effects of the medical treatment for AD thus the majority try to engage in potentially healthy lifestyle behaviours. The aim of this study was to exploratively investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in adult AD patients This study is a four-armed, randomised controlled, single-centre, open explorative clinical trial. Patients were randomly assigned to one of the four groups: i) hypnotherapy group program (HTP), ii) intermittent fasting with diet adjustment group program (IFDP), iii) an exercise group program or the control group. The study was strongly impacted by confinements and research restrictions due to the coronavirus 2019 pandemic. However, results showed potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Authors conclude that further high-quality clinical trials should be performed investigating the effectiveness and safety of hypnotherapy, fasting with diet adjustments, as well as exercise.
Abstract
Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.
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Effects of Gut Microbiome Modulation on Reducing Adverse Health Outcomes among Elderly and Diabetes Patients during the COVID-19 Pandemic: A Randomised, Double-Blind, Placebo-Controlled Trial (IMPACT Study).
Wong, MCS, Zhang, L, Ching, JYL, Mak, JWY, Huang, J, Wang, S, Mok, CKP, Wong, A, Chiu, OL, Fung, YT, et al
Nutrients. 2023;15(8)
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Worldwide, the coronavirus disease 2019 (COVID-19) pandemic has posed a substantial challenge in terms of its induced morbidity and mortality to the general population. Patients with diabetes and elderly individuals are particularly vulnerable during the pandemic. The aim of this study was to assess the efficacy of a novel microbiome immunity formula (SIM01) in reducing adverse health outcomes in the elderly and patients with type two diabetes mellitus during the COVID-19 pandemic. This study was a double-blind, randomised, parallel-arm, placebo-controlled trial. Participants were randomly assigned to receive a microbiome immunity formula (SIM01) or placebo in a 1:1 ratio for three months. Results showed that SIM01, could reduce adverse health outcomes, improve quality of life, and restore gut dysbiosis among elderly subjects and patients with type two diabetes during the COVID-19 pandemic. In fact, SIM01 not only replenished Bifidobacteria but also favoured the coexistence of other beneficial species. Authors conclude that their findings provide significant societal implications for strategies that could protect these vulnerable individuals during the COVID-19 pandemic.
Abstract
Gut microbiota is believed to be a major determinant of health outcomes. We hypothesised that a novel oral microbiome formula (SIM01) can reduce the risk of adverse health outcomes in at-risk subjects during the coronavirus disease 2019 (COVID-19) pandemic. In this single-centre, double-blind, randomised, placebo-controlled trial, we recruited subjects aged ≥65 years or with type two diabetes mellitus. Eligible subjects were randomised in a 1:1 ratio to receive three months of SIM01 or placebo (vitamin C) within one week of the first COVID-19 vaccine dose. Both the researchers and participants were blinded to the groups allocated. The rate of adverse health outcomes was significantly lower in the SIM01 group than the placebo at one month (6 [2.9%] vs. 25 [12.6], p < 0.001) and three months (0 vs. 5 [3.1%], p = 0.025). At three months, more subjects who received SIM01 than the placebo reported better sleep quality (53 [41.4%] vs. 22 [19.3%], p < 0.001), improved skin condition (18 [14.1%] vs. 8 [7.0%], p = 0.043), and better mood (27 [21.2%] vs. 13 [11.4%], p = 0.043). Subjects who received SIM01 showed a significant increase in beneficial Bifidobacteria and butyrate-producing bacteria in faecal samples and strengthened the microbial ecology network. SIM01 reduced adverse health outcomes and restored gut dysbiosis in elderly and diabetes patients during the COVID-19 pandemic.
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Effect of an Immune-Boosting, Antioxidant and Anti-Inflammatory Food Supplement in Hospitalized COVID-19 Patients: A Prospective Randomized Pilot Study.
Reino-Gelardo, S, Palop-Cervera, M, Aparisi-Valero, N, Espinosa-San Miguel, I, Lozano-Rodríguez, N, Llop-Furquet, G, Sanchis-Artero, L, Cortés-Castell, E, Rizo-Baeza, M, Cortés-Rizo, X
Nutrients. 2023;15(7)
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Coronavirus Disease 2019 (COVID-19), has spread worldwide, reaching pandemic proportions. The symptoms caused by COVID-19 disease are nonspecific and may range from asymptomatic to severe pneumonia and death. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. This study was a prospective, randomised, non-blinded clinical trial. A total of 162 patients were enrolled at Sagunto Hospital, 42.0% of whom were women. Participants were assigned to one of the two groups: probiotic or control group. Results showed that higher mortality was found in men, older patients and those with severe radiological involvement. Furthermore, administration of the food supplement product Gasteel Plus®, as an adjuvant to the treatment established in the hospital for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated pneumonia, reduced the duration of digestive symptoms and hospital stay in patients with mild–moderate pulmonary involvement. Authors conclude that their findings demonstrate the importance of considering the use of the food supplement under review in the prevention and treatment of SARS-CoV-2, including severe cases, which showed no side effects.
Abstract
BACKGROUND COVID-19 disease is a serious global health problem. Few treatments have been shown to reduce mortality and accelerate time to recovery. The aim of this study was to evaluate the potential effect of a food supplement (probiotics, prebiotics, vitamin D, zinc and selenium) in patients admitted with COVID-19. METHODS A prospective randomized non-blinded clinical trial was conducted in a sample of 162 hospitalized patients diagnosed with COVID-19 recruited over eight months. All patients received standard treatment, but the intervention group (n = 67) was given one food supplement stick daily during their admission. After collecting the study variables, a statistical analysis was performed comparing the intervention and control groups and a multivariate analysis controlling for variables that could act as confounding factors. RESULTS ROC curve analysis with an area under the curve (AUC) value of 0.840 (p < 0.001; 95%CI: 0.741-0.939) of the food supplement administration vs. recovery indicated good predictive ability. Moreover, the intervention group had a shorter duration of digestive symptoms compared with the control group: 2.6 ± 1.3 vs. 4.3 ± 2.2 days (p = 0.001); patients with non-severe disease on chest X-ray had shorter hospital stays: 8.1 ± 3.9 vs. 11.6 ± 7.4 days (p = 0.007). CONCLUSIONS In this trial, the administration of a food supplement (Gasteel Plus®) was shown to be a protective factor in the group of patients with severe COVID-19 and allowed early recovery from digestive symptoms and a shorter hospital stay in patients with a normal-mild-moderate chest X-ray at admission (ClinicalTrials.gov number, NCT04666116).
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REsCue trial: Randomized controlled clinical trial with extended-release calcifediol in symptomatic COVID-19 outpatients.
Bishop, CW, Ashfaq, A, Melnick, JZ, Vazquez-Escarpanter, E, Fialkow, JA, Strugnell, SA, Choe, J, Kalantar-Zadeh, K, Federman, NC, Ng, D, et al
Nutrition (Burbank, Los Angeles County, Calif.). 2023;107:111899
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Literature shows that vitamin D repletion may reduce the risk for infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), mitigate severity of coronavirus disease (COVID-19), and accelerate recovery. Sufficient serum level of 25-hydroxyvitamin D (25D) is postulated to potentiate COVID-19 vaccine effectiveness, boost innate and control adaptive immunity, and reduce post-infection cytokine storm and lung injury. The aim of this study was to evaluate the safety and efficacy of extended-release calcifediol capsules to treat symptomatic patients infected with SARS-CoV-2. This study is a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial titled REsCue. One hundred seventy-one symptomatic COVID-19 outpatients participants were enrolled. Patients were randomised (1:1) to 4 weeks of treatment with extended-release calcifediol (30 mcg/capsule) or matching placebo and a 2-week follow-up. Results show that extended-release calcifediol treatment was effective in increasing serum 25D levels to ≥50 ng/mL, which may have yielded significantly shorter resolution times for three aggregated respiratory symptoms (trouble breathing, chest congestion, and dry or hacking cough) commonly observed in patients with mild to moderate COVID-19. Authors conclude that the positive findings from this study warrant confirmation in additional larger studies.
Abstract
OBJECTIVES This double-blind randomized controlled trial investigated raising serum 25-hydroxyvitamin D (25D) with extended-release calcifediol (ERC) on time to symptom resolution in patients with mild to moderate COVID-19. METHODS COVID-19 outpatients received oral ERC (300 mcg on days 1-3 and 60 mcg on days 4-27) or placebo (NCT04551911). Symptoms were self-reported daily. Primary end points were raising 25D to ≥50 ng/mL and decreasing resolution time for five aggregated symptoms (three respiratory). RESULTS In all, 171 patients were randomized, 160 treated and 134 (65 ERC, 69 placebo) retained. The average age was 43 y (range 18-71), 59% were women. The mean baseline 25D was 37 ± 1 (SE) ng/mL. In the full analysis set (FAS), 81% of patients in the ERC group achieved 25D levels of ≥50 ng/mL versus 15% in the placebo group (P < 0.0001). In the per-protocol (PP) population, mean 25D increased with ERC to 82 ± 4 (SE) ng/mL (P < 0.0001) by day 7; the placebo group trended lower. Symptom resolution time was unchanged in the FAS by ERC (hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.695-1.390; P = 0.922). In the PP population, respiratory symptoms resolved 4 d faster when 25D was elevated above baseline level at both days 7 and 14 (median 6.5 versus 10.5 d; HR, 1.372; 95% CI, 0.945-1.991; P = 0.0962; Wilcoxon P = 0.0386). Symptoms resolved in both treatment groups to a similar extent by study end. Safety concerns including hypercalcemia were absent with ERC treatment. CONCLUSION ERC safely raised serum 25D to ≥50 ng/mL in outpatients with COVID-19, possibly accelerating resolution of respiratory symptoms and mitigating the risk for pneumonia. These findings warrant further study.
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Efficacy and Safety of the Adjuvant Use of Probiotic Bacillus clausii Strains in Pediatric Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.
Vázquez-Frias, R, Consuelo-Sánchez, A, Acosta-Rodríguez-Bueno, CP, Blanco-Montero, A, Robles, DC, Cohen, V, Márquez, D, Perez, M
Paediatric drugs. 2023;25(1):115-126
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Irritable bowel syndrome (IBS) is considered both a health and a socioeconomic burden. Curative treatment for IBS is currently not available and current management strategies vary. Gut microbiota dysbiosis is increasingly considered as a vital factor in the etiopathogenetic of IBS; thus, gut microbiota are a potential therapeutic target. The aim of this study was to investigate the efficacy and safety of Bacillus clausii plus conventional treatment, compared with placebo plus conventional treatment, in children with IBS in Mexico. This study is a phase III, multicentre, randomised, placebo-controlled, double-blind, parallel clinical trial. Patients (n=259) were centrally randomised 1:1 to treatment with either B. clausii or placebo. Results show that IBS symptom relief in children was very high in both groups (B. clausii and placebo). In fact, there weren’t any significant differences between groups for proportion of patients with clinical improvements at Week 8 or any of the key secondary endpoints. Furthermore, the adverse event profile was similar between groups. Authors conclude that their study was not able to demonstrate the efficacy of B. clausii as an adjuvant to conventional treatment of patients with IBS.
Abstract
OBJECTIVES Current irritable bowel syndrome (IBS) treatments have limited efficacy and probiotics like Bacillus clausii (B. clausii) were found to be effective in the management of several gastrointestinal disorders. This phase III trial assessed the efficacy and safety of adding B. clausii (four strains: O/C, N/R, SIN, T), versus placebo, to conventional treatment of pediatric IBS in Mexico. METHODS Patients aged 6-17 years 11 months with IBS (Rome IV) for at least 2 months were randomized to receive either B. clausii (oral suspension, total dose 4 billion spores/day) or placebo once daily for 8 weeks. All patients also received conventional treatment. The primary endpoint was the difference in the proportion of patients with clinical improvements at Week 8 (Global Assessment Questions [GAQ]). Secondary endpoints included responders by Subject's Global Assessment of Relief for Children with IBS (SGARC); number/consistency of stools; abdominal distention/bloating; abdominal pain/intensity; and IBS behavior. RESULTS 73.6% (95% confidence interval [CI] 67.3-80.0; B. clausii n = 129) and 78.5% (95% CI 72.5-84.4; placebo n = 130) of patients had symptom improvement (p = 0.8182). For Week 8 SGARC, 19.2% (B. clausii) and 20.9% (placebo) reported complete symptom relief. Stool evaluations, bloating, abdominal pain/intensity, and IBS behavior were similar between groups. Both treatments were well tolerated. CONCLUSION No significant differences in efficacy between B. clausii and placebo were demonstrated in addition to conventional treatment. The sample size calculation was based on an expected placebo/conventional treatment response of 30-40%. However, the actual treatment response observed was 80% and, thus, a study with larger population would be warranted. In addition, this study was conducted during the COVID-19 pandemic, when such controlled social conditions may have resulted in better diet, greater family stability, less psychological stress, and lower risk of infections exacerbating IBS, thereby improving symptoms in both groups. EUDRACT NUMBER 2018-004519-31.
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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)
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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.
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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)
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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.
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Effects of L-carnitine supplementation in patients with mild-to-moderate COVID-19 disease: a pilot study.
Talebi, SS, Ghasemi, M, Etminani-Esfahani, M, Mohammadi, Y, Haddadi, R
Pharmacological reports : PR. 2022;74(6):1296-1305
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Coronavirus is an enveloped single-stranded-RNA positive-sense virus that includes four subgroups called alpha, beta, delta, and gamma, of which beta type is responsible for coronavirus disease 2019 (COVID-19). Due to the nature of COVID-19, L-carnitine may be considered a suitable therapeutic supplement as it has shown promising results in some viral infections related to the respiratory system. The aim of this study was to evaluate the extent of changes in inflammatory factors, such as c-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), following L-carnitine supplementation. This study is a single-centre, prospective, randomised, double-blind, and pilot clinical trial. Seventy-six patients who were hospitalised with mild-to-moderate COVID-19 symptoms were enrolled for the study. They were randomly divided into intervention (n=33) and control (n=43) groups. Results show that L-carnitine supplementation can decrease inflammation caused by infection, increase oxygen saturation levels through improvements in oxygen delivery and decrease liver enzymes levels. Furthermore, the mean CRP and ESR levels in patients receiving L-carnitine were significantly reduced. Authors conclude that L-carnitine can be suggested as a pharmacological supplement in patients with COVID-19, but further research and clinical studies with larger sample sizes are needed to confirm and extend their findings.
Abstract
BACKGROUND The present single-center clinical trial was designed to evaluate the potential benefits of L-carnitine supplementation in patients with COVID-19 disease. METHODS AND PATIENTS The study was conducted on 75 patients with mild-to-moderate COVID-19 hospitalized in Shahid Beheshti Hospital-Hamadan, IRAN. The participants were randomly divided into intervention (n = 32) and control groups (n = 43). The control group received their standard hospital treatment only. In addition to standard medications, the intervention group received 3000 mg oral L-carnitine daily in three divided doses for five days. The blood samples were collected and para-clinical parameters were measured at the beginning and end of the treatment. Clinical outcomes were also recorded, and data were analyzed using χ2 and t-tests. RESULTS Higher means of O2 saturation were observed in the intervention rather than in the control group. Mean erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were significantly lower in the intervention group. Furthermore, mean alkaline phosphatase (ALP) activity and lactate dehydrogenase (LDH) were lower in the intervention group. Also, lower mean serum creatine phosphokinase (CPK) was observed in the intervention group. No significant differences were observed in terms of clinical symptoms; however, six patients (14%) in the control group died due to the complications of COVID-19, while all patients in the intervention group survived. CONCLUSION Taken together, L-carnitine can be considered as a drug supplement in patients with COVID-19.