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Clinical significance of nutritional risk screening for older adult patients with COVID-19.
Liu, G, Zhang, S, Mao, Z, Wang, W, Hu, H
European journal of clinical nutrition. 2020
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Literature shows that nutritional deficiency is common and serious in the elderly, with studies reporting malnourishment in 35–65% of elderly hospitalized patients and 25–60% of institutionalized older adults. The aim of this study to explore the relationship between nutritional risk and clinical outcome in patients older than 65 years with COVID-19. A secondary outcome was to investigate the ability of the (nutritional risk screening) NRS tools to predict worse-than-average clinical outcomes. The study is a retrospective cohort analysis which enrolled 141 patients (females n = 73). Patients were classified into either a normal group or a nutritional risk group according to the criterion of each NRS tool. Results indicate that patients with COVID-19 who classified as having a nutritional risk had significantly poorer clinical outcomes than those classified as normal following assessments by Nutrition Risk Screening 2002 (NRS 2002), Mini Nutrition Assessment Shortcut (MNA-sf), and Nutrition Risk Index (NRI). Authors conclude that the NRS 2002, MNAsf, and NRI are useful and practical tools for identifying older adult patients with COVID-19 who are at nutritional risk.
Abstract
OBJECTIVES The aim of this study was to assess the nutritional risks among older patients with COVID-19 and their associated clinical outcomes using four nutritional risk screening (NRS) tools: Nutrition Risk Screening 2002 (NRS 2002), Malnutrition Universal Screening Tool (MUST), Mini Nutrition Assessment Shortcut (MNA-sf), and Nutrition Risk Index (NRI). METHODS We retrospectively analyzed the data of patients with COVID-19 older than 65 years who were treated in our hospital from January 28, 2020 to March 5, 2020, and explored the relationship between nutritional risk and clinical outcomes. RESULTS A total of 141 patients with COVID-19 (46 common COVID-19, 73 severe COVID-19, and 22 extremely severe COVID-19) were enrolled in the study. NRS 2002 identified 85.8% of patients as having risk, with being identified 41.1% by MUST, 77.3% by MNA-sf, and 71.6% by NRI. The agreement strength was moderate between NRS 2002 and MNA-sf, NRI, fair between MUST and MNA-sf, NRI, fair between MNA-sf and NRI, poor between NRS 2002 and MUST (P < 0.01). After adjustment for confounding factors in multivariate regression analysis, patients in the risk group had significantly longer LOS, higher hospital expenses (except MNA-sf), poor appetite, heavier disease severity, and more weight change(kg) than normal patients by using NRS 2002, MNA-sf, and NRI(P < 0.05). CONCLUSIONS The NRS 2002, MNA-sf, and NRI are useful and practical tools with respect to screening for patients with COVID-19 who are at nutritional risk, as well as in need of additional nutritional intervention.
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Nutrition and lifestyle intervention in type 2 diabetes: pilot study in the Netherlands showing improved glucose control and reduction in glucose lowering medication
BMJ Nutrition, Prevention & Health aims to present the best available evidence of the impact of nutrition and lifestyle factors on the health of individuals and populations. The journal will present robust research on the key determinants of health including the social, economic, and physical environment, as well as lifestyle and behaviour. It will explore dietary factors, exercise and healthcare interventions and technologies, which aim to maintain and improve health and wellbeing and to prevent illness and injury.
2020
Abstract
The incidence of type 2 diabetes continues to rise. However, there is increasing evidence and discussion, that diet and lifestyle interventions can effectively reverse this trend. This 6 month, observational study of 73 individuals aged between 30-70 years, aimed to assess the impact of a nutrition and lifestyle group based intervention on blood glucose control and diabetic medication use. The intervention consisted of 4 one or two day workshops to introduce dietary and lifestyle measures and regular communication between workshops via closed group social media forums. At the end of the 6 month intervention, HbA1C levels had fallen by on average 5mmol/mol and the amount of diabetic medication use had dropped by 13%. Fasting blood glucose levels, BMI, body weight and waist circumference had also all dropped. The authors conclude that a group programme focusing on diet and lifestyle can effectively improve blood glucose control and lower medication use and call for larger trials.
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People with Suspected COVID-19 Symptoms Were More Likely Depressed and Had Lower Health-Related Quality of Life: The Potential Benefit of Health Literacy.
Nguyen, HC, Nguyen, MH, Do, BN, Tran, CQ, Nguyen, TTP, Pham, KM, Pham, LV, Tran, KV, Duong, TT, Tran, TV, et al
Journal of clinical medicine. 2020;9(4)
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COVID-19 has been spreading to a growing number of countries and is recognized as a global health concern that has set global public health institutions on high alert. Improving health literacy is a strategic approach to preventing and controlling diseases. The aim of this study was to investigate the association of suspected COVID-19 symptoms (S-COVID-19-S) with depression and health related quality of life (HRQoL), and the effect modification of health literacy on the associations among people who visited outpatient departments. This is a cross-sectional study which recruited participants (aged between 18 and 85 years) from outpatient departments of six hospitals and three health centers across Vietnam. Results indicate that participants with S-COVID-19-S had a higher likelihood of depression and lower HRQoL. Whereas, those participants having S-COVID-19-S and with higher health literacy had a low occurrence of depression and better HRQoL compared to those people with lower health literacy. Authors conclude that health literacy can help to protect the mental health and HRQoL of people with S-COVID-19-S during the pandemic.
Abstract
undefined: The coronavirus disease 2019 (COVID-19) epidemic affects people's health and health-related quality of life (HRQoL), especially in those who have suspected COVID-19 symptoms (S-COVID-19-S). We examined the effect of modifications of health literacy (HL) on depression and HRQoL. A cross-sectional study was conducted from 14 February to 2 March 2020. 3947 participants were recruited from outpatient departments of nine hospitals and health centers across Vietnam. The interviews were conducted using printed questionnaires including participants' characteristics, clinical parameters, health behaviors, HL, depression, and HRQoL. People with S-COVID-19-S had a higher depression likelihood (OR, 2.88; < 0.001), lower HRQoL-score (B, -7.92; < 0.001). In comparison to people without S-COVID-19-S and low HL, those with S-COVID-19-S and low HL had 9.70 times higher depression likelihood ( < 0.001), 20.62 lower HRQoL-score ( < 0.001), for the people without S-COVID-19-S, 1 score increment of HL resulted in 5% lower depression likelihood ( < 0.001) and 0.45 higher HRQoL-score ( < 0.001), while for those people with S-COVID-19-S, 1 score increment of HL resulted in a 4% lower depression likelihood ( = 0.004) and 0.43 higher HRQoL-score ( < 0.001). People with S-COVID-19-S had a higher depression likelihood and lower HRQoL than those without. HL shows a protective effect on depression and HRQoL during the epidemic.
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The Effectiveness of Intermittent Fasting to Reduce Body Mass Index and Glucose Metabolism: A Systematic Review and Meta-Analysis.
Cho, Y, Hong, N, Kim, KW, Cho, SJ, Lee, M, Lee, YH, Lee, YH, Kang, ES, Cha, BS, Lee, BW
Journal of clinical medicine. 2019;8(10)
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Calorie restriction (CR) is known to reduce body weight and to improve various cardiovascular risk factors. Due to the many difficulties in sustaining daily CR, intermittent fasting (IF) has been proposed as an alternative strategy for achieving and maintaining weight reduction. The aim of this study was to investigate the effectiveness of IF on weight loss and glucose metabolism by analysing the effect size of previous studies among the general population without diabetes mellitus. A total of 12 studies were included in this study. The total number of participants was 545 (261 in the intervention group and 284 in the control group). Study analysis indicates an improvement in glycaemic control and insulin resistance through IF diet as compared with a non-fasting control group. Lean mass was relatively conserved in the IF diet group however, no significant weight reduction was identified. Authors conclude that IF diet may improve fat distribution in the general population without chronic metabolic disease.
Abstract
undefined: The effects of an intermittent fasting diet (IFD) in the general population are still controversial. In this study, we aimed to systematically evaluate the effectiveness of an IFD to reduce body mass index and glucose metabolism in the general population without diabetes mellitus. Cochrane, PubMed, and Embase databases were searched to identify randomized controlled trials and controlled clinical trials that compared an IFD with a regular diet or a continuous calorie restriction diet. The effectiveness of an IFD was estimated by the weighted mean difference (WMD) for several variables associated with glucometabolic parameters including body mass index (BMI) and fasting glucose. The pooled mean differences of outcomes were calculated using a random effects model. From 2814 studies identified through a literature search, we finally selected 12 articles (545 participants). Compared with a control diet, an IFD was associated with a significant decline in BMI (WMD, -0.75 kg/m ; 95% CI, -1.44 to -0.06), fasting glucose level (WMD, -4.16 mg/dL; 95% CI, -6.92 to -1.40), and homeostatic model assessment of insulin resistance (WMD, -0.54; 95% CI, -1.05 to -0.03). Fat mass (WMD, -0.98 kg; 95% CI, -2.32 to 0.36) tended to decrease in the IFD group with a significant increase in adiponectin (WMD, 1008.9 ng/mL; 95% CI, 140.5 to 1877.3) and a decrease in leptin (WMD, -0.51 ng/mL; 95% CI, -0.77 to -0.24) levels. An IFD may provide a significant metabolic benefit by improving glycemic control, insulin resistance, and adipokine concentration with a reduction of BMI in adults.
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Natural Choline from Egg Yolk Phospholipids Is More Efficiently Absorbed Compared with Choline Bitartrate; Outcomes of A Randomized Trial in Healthy Adults.
Smolders, L, de Wit, NJW, Balvers, MGJ, Obeid, R, Vissers, MMM, Esser, D
Nutrients. 2019;11(11)
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Choline is a water-soluble vitamin-like essential nutrient. Although the liver can produce small amounts of choline, choline needs to be obtained through the diet to avoid deficiencies. The aim of this study was to evaluate choline bioavailability in healthy adults after the consumption of an egg yolk phospholipid drink and compare it to a control drink containing chemically produced choline. The study was a randomized, cross-over, double blind, controlled trial which recruited eighteen healthy adults (n = 7 men and n = 11 women) with an age range between 30 and 70 years. The two test drinks were administered in randomized order. Results showed that choline is better absorbed when it is consumed in the natural form; choline absorption was 4 times higher when compared to egg yolk phospholipid consumption with chemically produced choline. Authors conclude that their findings can be particularly relevant for the development of infant formula, supplements and functional foods. They suggest that instead of adding choline as a salt, adding choline from egg yolk phospholipids can improve choline uptake and, thereby, have a positive impact on health.
Abstract
undefined: Choline is a vitamin-like essential nutrient, important throughout one's lifespan. Therefore, choline salts are added to infant formula, supplements and functional foods. However, if choline is present in a natural form, e.g. bound to phospholipids, it may be more efficiently absorbed. The study's aim was to evaluate if choline uptake is improved after consumption of an egg yolk phospholipid drink, containing 3 g of phospholipid bound choline, compared to a control drink with 3 g of choline bitartrate. We performed a randomized, double blind, cross-over trial with 18 participants. Plasma choline, betaine and dimethylglycine concentrations were determined before and up to six hours after consumption of the drinks. The plasma choline response, as determined by the incremental area under the curve, was four times higher after consumption of the egg yolk phospholipid drink compared with the control drink ( 0.01). Similar outcomes were also observed for choline's main metabolites, betaine ( 0.01) and dimethylglycine ( 0.01). Consumption of natural choline from egg yolk phospholipids improved choline absorption compared to consumption of chemically produced choline bitartrate. This information is of relevance for the food industry, instead of adding choline-salts, adding choline from egg yolk phospholipids can improve choline uptake and positively impact health.
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Effects of aquatic exercise on mental health, functional autonomy and oxidative stress in depressed elderly individuals: A randomized clinical trial.
Silva, LAD, Tortelli, L, Motta, J, Menguer, L, Mariano, S, Tasca, G, Silveira, GB, Pinho, RA, Silveira, PCL
Clinics (Sao Paulo, Brazil). 2019;74:e322
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Decreased physical activity can contribute significantly to increased levels of depression. Whereas, regular physical activity positively alters the symptoms of depression thereby promoting mental health. The aim of this study was to investigate the effects of aquatic exercise on mental health, functional autonomy and oxidative stress parameters in depressed elderly individuals. The study is a longitudinal clinical study, conducted over a period of 12 weeks. Forty participants were recruited: 20 elderly individuals (men n = 9 men) with depression formed the depression group and another 20 (n = 13 men) individuals without depression formed the non-depression group. Both groups were subjected to the same aquatic physical training program. Results showed that a low-intensity aerobic training program in the aquatic environment can contribute to the treatment of depression by reducing anxiety and depression scores, improving functional autonomy and decreasing oxidative stress. Authors conclude that an intermittent aquatic physical exercise program improves the functional capacity of depressed elderly individuals.
Abstract
OBJECTIVES The aim of this study was to investigate the effects of aquatic exercise on mental health, functional autonomy and oxidative stress parameters in depressed elderly individuals. METHODS Initially, ninety-two elderly individuals were included in the study and were allocated into the depression group (n=16) and nondepression group (n=14). Both groups engaged in the aquatic exercise program for 12 weeks, including two weekly sessions (45 min/session) at a low intensity (between 50% and 60% of maximal heart rate or Borg scale scores of 13 to 14) throughout the intervention. All outcomes were evaluated at baseline and 12 weeks later. RESULTS The patients were 63.5±8.8 years old. The following scores were decreased after training in the depressed group: depression (53%), anxiety (48%), and Timed Up & Go (33%). The following scores increased: Berg Balance Scale (9%) and flexibility (44%). Regarding the blood-based parameters, there were decreases in protein carbonylation (46%) and nitric oxide (60%) and increases in glutathione (170%) and superoxide dismutase (160%) in the depression group (p<0.005). CONCLUSIONS The aquatic exercise program reduces depression and anxiety, improves functional autonomy and decreases oxidative stress in depressed elderly individuals.
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Cashew apple juice supplementation enhances leukocyte count by reducing oxidative stress after high-intensity exercise in trained and untrained men.
Prasertsri, P, Roengrit, T, Kanpetta, Y, Tong-Un, T, Muchimapura, S, Wattanathorn, J, Leelayuwat, N
Journal of the International Society of Sports Nutrition. 2019;16(1):31
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High-intensity aerobic training has been shown to suppress leukocyte counts in moderately fit athletes. The aim of this study to explore possible advantageous effects of cashew apple juice (CAJ) supplementation, and, if present, to identify the possible mechanisms underlying those effects. The study is a double-blind randomised cross-over design with two treatment arms: CAJ supplementation and placebo. Ten moderately (endurance) trained and untrained men were randomized to one of the two groups for four weeks, with a four-week wash out period. Results showed that CAJ supplementation for four weeks increased leukocyte (a type of blood cell) counts, while simultaneously decreasing oxidative stress, following an acute bout of high-intensity exercise in trained men. Furthermore, the CAJ supplementation increased neutrophil (a type of white blood cell) counts while simultaneously reducing oxidative stress and stress hormone concentrations in untrained men. The antioxidant effects following exercise were observed in both endurance-trained and untrained men. Authors conclude that CAJ supplementation is beneficial to men, both in resting states and in response to an acute bout of high-intensity aerobic exercise.
Abstract
BACKGROUND Cashew apple juice (CAJ) was shown to improve immunological mechanisms by regulating a balance between reactive oxygen species and antioxidant concentrations. However, no study exploring the effects of the CAJ and training status on the immune system and oxidative stress induced by exercise. Therefore, we investigated the effects of CAJ supplementation primarily on leukocyte counts and secondary on oxidative stress and cortisol changes after high-intensity exercise in trained and untrained men. METHODS Ten moderately (endurance) trained (Age = 21.5 ± 0.97 yr., VO2max = 45.6 ± 4.12 mL/kgBM/min) and ten sedentary men (Age = 20.4 ± 2.72 yr., VO2peak = 32.2 ± 7.26 mL/kgBM/min) were randomized to ingest either daily CAJ or a placebo at 3.5 mL/kgBM/day for 4 weeks, with a four-week washout period. Before and after each period, they performed 20-min, high-intensity cycling (85% VO2max), with blood samples collected immediately preceding and the following exercise. Samples were analyzed to determine leukocyte counts, malondialdehyde, 8-isoprostane, and cortisol concentrations. A repeated measures analysis of variance was used to examine the effects of supplement and training status over time with an alpha level of 0.05. RESULTS There was no interaction between supplement and training status on those variables before and after exercise. However, CAJ raised resting neutrophil counts and exercise-induced leukocyte counts in the trained group (all p < 0.05). Besides, CAJ significantly reduced plasma malondialdehyde concentrations at rest and after exercise and reduced the post-exercise plasma 8-isoprostane concentration in both groups of subjects (p < 0.05). Moreover, CAJ reduced plasma cortisol after exercise in the untrained subjects. CONCLUSIONS We suggest that 4-week CAJ supplementation can enhance exercise-induced leukocyte and resting neutrophil counts in trained men. The possible mechanism is a reduction in oxidative stress. However, the supplementation did not change the immune responses of untrained men, but it did reduce stress hormone concentrations. TRIAL REGISTRATION NUMBER TCTR20181127002 Registered 26 November 2018 "retrospectively registered".
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Dietary supplementation with inulin-propionate ester or inulin improves insulin sensitivity in adults with overweight and obesity with distinct effects on the gut microbiota, plasma metabolome and systemic inflammatory responses: a randomised cross-over trial.
Chambers, ES, Byrne, CS, Morrison, DJ, Murphy, KG, Preston, T, Tedford, C, Garcia-Perez, I, Fountana, S, Serrano-Contreras, JI, Holmes, E, et al
Gut. 2019;68(8):1430-1438
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Literature shows that higher intakes of dietary fibre are associated with a reduced risk of type 2 diabetes. The main aim of this study was to elucidate the underlying mechanisms behind improvements in glucose homeostasis following long-term delivery of propionate (a short-chain fatty acid produced by human gut microbiota in response to dietary fibre) to the human colon. The study is a randomised, double-blind, placebo-controlled cross over trial. Fourteen participants randomly received 20 g/day of a low-fermentable fibre control, a high-fermentable fibre control and inulin-propionate ester (IPE) for 42 days each. Results indicate that stool concentrations of short-chain fatty acids were not different following the three supplementation periods. Furthermore, dietary supplementation with 20 g/day IPE promoted no superior impacts on measures of glucose homeostasis compared with inulin (high-fermentable fibre), yet both IPE and inulin improved insulin resistance relative to cellulose (low-fermentable fibre). Authors conclude that manipulating the colonic fermentation profile of a dietary fibre in favour of propionate promotes selective effects on the mechanisms that contribute to metabolic dysregulation.
Abstract
OBJECTIVE To investigate the underlying mechanisms behind changes in glucose homeostasis with delivery of propionate to the human colon by comprehensive and coordinated analysis of gut bacterial composition, plasma metabolome and immune responses. DESIGN Twelve non-diabetic adults with overweight and obesity received 20 g/day of inulin-propionate ester (IPE), designed to selectively deliver propionate to the colon, a high-fermentable fibre control (inulin) and a low-fermentable fibre control (cellulose) in a randomised, double-blind, placebo-controlled, cross-over design. Outcome measurements of metabolic responses, inflammatory markers and gut bacterial composition were analysed at the end of each 42-day supplementation period. RESULTS Both IPE and inulin supplementation improved insulin resistance compared with cellulose supplementation, measured by homeostatic model assessment 2 (mean±SEM 1.23±0.17 IPE vs 1.59±0.17 cellulose, p=0.001; 1.17±0.15 inulin vs 1.59±0.17 cellulose, p=0.009), with no differences between IPE and inulin (p=0.272). Fasting insulin was only associated positively with plasma tyrosine and negatively with plasma glycine following inulin supplementation. IPE supplementation decreased proinflammatory interleukin-8 levels compared with cellulose, while inulin had no impact on the systemic inflammatory markers studied. Inulin promoted changes in gut bacterial populations at the class level (increased Actinobacteria and decreased Clostridia) and order level (decreased Clostridiales) compared with cellulose, with small differences at the species level observed between IPE and cellulose. CONCLUSION These data demonstrate a distinctive physiological impact of raising colonic propionate delivery in humans, as improvements in insulin sensitivity promoted by IPE and inulin were accompanied with different effects on the plasma metabolome, gut bacterial populations and markers of systemic inflammation.
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Adherence to the Mediterranean Diet and Its Association with Body Composition and Physical Fitness in Spanish University Students.
Cobo-Cuenca, AI, Garrido-Miguel, M, Soriano-Cano, A, Ferri-Morales, A, Martínez-Vizcaíno, V, Martín-Espinosa, NM
Nutrients. 2019;11(11)
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The Mediterranean diet (MD) represents a dietary pattern that incorporates healthy traditional eating habits which includes high consumption of vegetables, fruit, legumes, nuts, beans, whole grains, fish, and unsaturated fats, and low consumption of red meat and dairy products. The Mediterranean Diet Adherence Screener (MEDAS-14 items) is a valid instrument for the estimation of adherence to the MD. The objectives of this study were to: 1. Estimate the prevalence of the adherence to the MD 2. Assess the association of adherence to the MD with physical fitness and body composition 3. Know the ability of each MEDAS item in the same sample to predict MD adherence. This study is a cross-sectional observational study which was performed with 310 first-year Spanish university students, aged between 18 and 30 years. Results indicate low prevalence of good adherence to the MD; and the participants with good adherence had high protein and low-fat intake compared to those with medium to low adherence. Furthermore, higher levels of physical fitness were also noticed amongst participants with good adherence to the MD. Twelve of the 14 items of the MEDAS score were associated with a high adherence to the MD. Authors conclude that MD adherence benefits both cardiorespiratory and muscular fitness amongst young adults.
Abstract
undefined: The aims of this study were to assess the association of adherence to the Mediterranean diet (MD) with physical fitness and body composition in Spanish university students and to determine the ability to predict the MD adherence of each Mediterranean Diet Adherence Screener (MEDAS) item. A cross-sectional study was performed involving 310 first-year university students. Adherence to the MD was evaluated with MEDAS-14 items. Anthropometric variables, body composition, and physical fitness were assessed. Muscle strength was determined based on handgrip strength and the standing long jump test. Cardiorespiratory fitness (CRF) was measured using the Course-Navette test. Only 24% of the university students had good adherence to the MD. The ANCOVA models showed a significant difference between participants with high adherence to the MD and those with medium and low adherence in CRF ( = 0.017) and dynamometry ( = 0.005). Logistic binary regression showed that consuming >2 vegetables/day (OR = 20.1; CI: 10.1-30.1; < 0.001), using olive oil (OR = 10.6; CI: 1.4-19.8; = 0.021), consuming <3 commercial sweets/week (OR = 10.1; IC: 5.1-19.7; < 0.001), and consuming ≥3 fruits/day (OR = 8.8; CI: 4.9-15.7; < 0.001) were the items most associated with high adherence to the MD. In conclusion, a high level of adherence to the MD is associated with high-level muscular fitness and CRF in Spanish university students.
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Vitamin D for the Immune System in Cystic Fibrosis (DISC): a double-blind, multicenter, randomized, placebo-controlled clinical trial.
Tangpricha, V, Lukemire, J, Chen, Y, Binongo, JNG, Judd, SE, Michalski, ES, Lee, MJ, Walker, S, Ziegler, TR, Tirouvanziam, R, et al
The American journal of clinical nutrition. 2019;109(3):544-553
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Patients with cystic fibrosis (CF) have a mutation in a particular gene which results in derangements in chloride transport across epithelial surfaces, leading to abnormally thickened mucus on the surfaces of the lung, pancreas, intestines, and other organs. The aim of this study was to investigate the impact of high-dose vitamin D3 administered to adults with CF during and after an acute pulmonary exacerbation. The study is a double-blind, randomised, placebo-controlled clinical trial. Subjects were randomly assigned and stratified to one of the two groups: vitamin D (5 capsules of vitamin D3 containing 50,000 IU) or placebo (5 capsules that were identical in size, shape, and colour to the vitamin D3 capsule). Results demonstrated that high-dose vitamin D3 administration to adults with CF initiated at the time of a pulmonary exacerbation did not improve time to next pulmonary exacerbation or 1 year survival. Authors conclude that a high-dose vitamin D3 bolus, combined with maintenance therapy given to adults with CF during acute pulmonary exacerbation of CF did not improve 1 year survival or recovery of lung function.
Abstract
BACKGROUND Patients with cystic fibrosis (CF) have increased risk of vitamin D deficiency owing to fat malabsorption and other factors. Vitamin D deficiency has been associated with increased risk of pulmonary exacerbations of CF. OBJECTIVES The primary objective of this study was to examine the impact of a single high-dose bolus of vitamin D3 followed by maintenance treatment given to adults with CF during an acute pulmonary exacerbation on future recurrence of pulmonary exacerbations. METHODS This was a multicenter, double-blind, placebo-controlled, intent-to-treat clinical trial. Subjects with CF were randomly assigned to oral vitamin D3 given as a single dose of 250,000 International Units (IU) or to placebo within 72 h of hospital admission for an acute pulmonary exacerbation, followed by 50,000 IU of vitamin D3 or an identically matched placebo pill taken orally every other week starting at 3 mo after random assignment. The primary outcome was the composite endpoint of the time to next pulmonary exacerbation or death within 1 y. The secondary outcomes included circulating concentrations of the antimicrobial peptide cathelicidin and recovery of lung function as assessed by the percentage of predicted forced expiratory volume in 1 s (FEV1%). RESULTS A total of 91 subjects were enrolled in the study. There were no differences between the vitamin D3 and placebo groups in time to next pulmonary exacerbation or death at 1 y. In addition, there were no differences in serial recovery of lung function after pulmonary exacerbation by FEV1% or in serial concentrations of plasma cathelicidin. CONCLUSIONS Vitamin D3 initially given at the time of pulmonary exacerbation of CF did not alter the time to the next pulmonary exacerbation, 12-mo mortality, serial lung function, or serial plasma cathelicidin concentrations. This trial was registered at clinicaltrials.gov as NCT01426256.
