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Optimizing Vitamin and Trace Element Profiles in Blood after Gastrointestinal Tract Surgery by a New Parenteral Nutrition Formula.
Fukatsu, K, Shineha, R, Kawauchi, Y, Saeki, M, Nakayama, M
Annals of nutrition & metabolism. 2019;(3):189-199
Abstract
INTRODUCTION Though micronutrient formulations for parenteral nutrition (PN) have been revised, the impacts of these changes on nutritional parameters, blood micronutrient levels, and safety have yet to be clarified. We examined the efficacy and safety of a new PN formulation with a micronutrient composition based on the Food and Drug Administration 2000 recommendation in surgical patients. METHODS This phase III clinical trial (JapicCTI-No. 142610) was a prospective, randomized, controlled, parallel-group, open-label, multicenter study. Two types of PN, OPF-108 (revised formula, n = 51) and ELN (previous formula mainly based on American Medical Association 1975 guidelines, n = 59), were given to patients from POD1 or 2 to POD7 after surgery. OPF-108 contains more vitamin B1, B6, C, and folic acid, a much lower dose of vitamin K, and less iron than ELN. Nutritional parameters and micronutrient profiles in blood and safety were evaluated. RESULTS Nutritional parameters on POD5 and 8 were similar between the 2 groups. Blood vitamin B1, B6, and folic acid levels on POD 5 and 8 were higher in the OPF-108 group than in the ELN group. Only OPF-108 restored vitamin C levels to within the normal range on POD5 and 8. Vitamin K levels far exceeded the upper limit of the standard range on POD5 and 8 in the ELN group, whereas OPF-108 essentially maintained these levels within the standard ranges. Serum iron levels on POD8 were nearly normal in both the OPF-108 and ELN groups. CONCLUSION Beneficial effects of the new micronutrient formulation were demonstrated in surgical patients.
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Immune function testing in sepsis patients receiving sodium selenite.
Guo, A, Srinath, J, Feuerecker, M, Crucian, B, Briegel, J, Boulesteix, AL, Kaufmann, I, Choukèr, A
Journal of critical care. 2019;:208-212
Abstract
PURPOSE We examined in a longitudinal study the role of sodium selenite in sepsis patients in strengthening the immune performance in whole blood samples using immune functional assays. MATERIALS AND METHODS This was a sub-study from a randomized, double blinded multicenter clinical trial (SISPCT) registered with www.clinicaltrials.gov (NCT00832039) and with data collected at our center. Full blood samples were incubated with various recall antigens and the supernatants were measured for their cytokine concentrations as markers for immune response. Data from days 0, 4, 7, 14, and 21 (from sepsis onset) were analyzed using a generalized least squares model in R to appropriately take the longitudinal structure and the missing values into account. RESULTS From the 76 patients enrolled in the study at our center, 40 were randomized to selenium therapy and 36 to placebo. The analyses of immune response assay data showed no statistical difference between the selenium and placebo groups at each of the time points. There was however an overall dampening of cytokine release, which tended to recover over time in both groups. CONCLUSION Selenium has long been an adjuvant therapy in treating sepsis. Recently, it was proven to not have beneficial effects on the mortality outcome. Using data from our center in this sub-cohort study, we identified no relative improvement in cytokine release of stimulated blood immune cells ex vivo from patients with selenium therapy over a three-week period. This offers a potential explanation for the lack of beneficial effects of selenium in sepsis patients.
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Selenium supplementation in the management of thyroid autoimmunity during pregnancy: results of the "SERENA study", a randomized, double-blind, placebo-controlled trial.
Mantovani, G, Isidori, AM, Moretti, C, Di Dato, C, Greco, E, Ciolli, P, Bonomi, M, Petrone, L, Fumarola, A, Campagna, G, et al
Endocrine. 2019;(3):542-550
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Abstract
PURPOSE Selenium is frequently in nutraceuticals for pregnancy, given its role on fertility and thyroid metabolism. However, most evidence rise from non-controlled studies. We aimed to evaluate the protective effect of selenium against thyroid autoimmunity during and after pregnancy. METHODS A multicenter, randomized, double-blind, placebo-controlled trial was performed and promoted by the Young Italian Endocrinologists Group (EnGioI)-Italian Society of Endocrinology. Forty-five women with thyroiditis in pregnancy were enrolled and randomly assigned to L-selenomethionine (L-Se-Met) 83 mcg/day or placebo (PLB) and evaluated at 10 ± 2 (T1), 36 ± 2 weeks of gestation (T2) and 6 months after delivery (postpartum, PP). RESULTS We measured a significant reduction of autoantibodies after pregnancy in L-Se-Met group [at PP: TgAb 19.86 (11.59-52.60), p < 0.01; TPOAb 255.00 (79.00-292.00), p < 0.01], and an antibodies titer's rebound in PLB group (TgAb 151.03 ± 182.9, p < 0.01; TPOAb 441.28 ± 512.18, p < 0.01). A significant increase in selenemia was measured in L-Se-Met group at T2 (91.33 ± 25.49; p < 0.01) and PP (93.55 ± 23.53; p = 0.02). Two miscarriage occurred in PLB. No differences were found in thyroid volume, echogenicity, quality of life, maternal/fetal complications. CONCLUSIONS SERENA study demonstrated a beneficial effect of L-Se-Met supplementation on autoantibody titer during pregnancy and on postpartum thyroiditis recurrence.
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Renal function in patients with non-dialysis chronic kidney disease receiving intravenous ferric carboxymaltose: an analysis of the randomized FIND-CKD trial.
Macdougall, IC, Bock, AH, Carrera, F, Eckardt, KU, Gaillard, C, Van Wyck, D, Meier, Y, Larroque, S, Roger, SD, ,
BMC nephrology. 2017;(1):24
Abstract
BACKGROUND Preclinical studies demonstrate renal proximal tubular injury after administration of some intravenous iron preparations but clinical data on renal effects of intravenous iron are sparse. METHODS FIND-CKD was a 56-week, randomized, open-label, multicenter study in which patients with non-dialysis dependent chronic kidney disease (ND-CKD), anemia and iron deficiency without erythropoiesis-stimulating agent therapy received intravenous ferric carboxymaltose (FCM), targeting either higher (400-600 μg/L) or lower (100-200 μg/L) ferritin values, or oral iron. RESULTS Mean (SD) eGFR at baseline was 34.9 (11.3), 32.8 (10.8) and 34.2 (12.3) mL/min/1.73 m2 in the high ferritin FCM (n = 97), low ferritin FCM (n = 89) and oral iron (n = 167) groups, respectively. Corresponding values at month 12 were 35.6 (13.8), 32.1 (12.7) and 33.4 (14.5) mL/min/1.73 m2. The pre-specified endpoint of mean (SE) change in eGFR from baseline to month 12 was +0.7 (0.9) mL/min/1.73 m2 with high ferritin FCM (p = 0.15 versus oral iron), -0.9 (0.9) mL/min/1.73 m2 with low ferritin FCM (p = 0.99 versus oral iron) and -0.9 (0.7) mL/min/1.73 m2 with oral iron. No significant association was detected between quartiles of FCM dose, change in ferritin or change in TSAT versus change in eGFR. Dialysis initiation was similar between groups. Renal adverse events were rare, with no indication of between-group differences. CONCLUSION Intravenous FCM at doses that maintained ferritin levels of 100-200 μg/L or 400-600 μg/L did not negatively impact renal function (eGFR) in patients with ND-CKD over 12 months versus oral iron, and eGFR remained stable. These findings show no evidence of renal toxicity following intravenous FCM over a 1-year period. TRIAL REGISTRATIONS ClinicalTrials.gov NCT00994318 (first registration 12 October 2009).
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A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial.
Cereda, E, Klersy, C, Serioli, M, Crespi, A, D'Andrea, F, ,
Annals of internal medicine. 2015;(3):167-74
Abstract
BACKGROUND Trials on specific nutritional supplements for the treatment of pressure ulcers (PUs) have been small, inconsistent in their formulations, or unsuccessful in controlling for total supplement calorie or protein content. OBJECTIVE To evaluate whether supplementation with arginine, zinc, and antioxidants within a high-calorie, high-protein formula improves PU healing. DESIGN Multicenter, randomized, controlled, blinded trial. (ClinicalTrials.gov: NCT01107197). SETTING Long-term care and home care services. PATIENTS 200 adult malnourished patients with stage II, III, and IV PUs. INTERVENTIONS An energy-dense, protein-rich oral formula enriched with arginine, zinc, and antioxidants (400 mL/d) or an equal volume of an isocaloric, isonitrogenous formula for 8 weeks. MEASUREMENTS The primary end point was the percentage of change in PU area at 8 weeks. Secondary end points included complete healing, reduction in the PU area of 40% or greater, incidence of wound infections, the total number of dressings at 8 weeks, and the percentage of change in area at 4 weeks. RESULTS Supplementation with the enriched formula (n = 101) resulted in a greater reduction in PU area (mean reduction, 60.9% [95% CI, 54.3% to 67.5%]) than with the control formula (n = 99) (45.2% [CI, 38.4% to 52.0%]) (adjusted mean difference, 18.7% [CI, 5.7% to 31.8%]; P = 0.017). A more frequent reduction in area of 40% or greater at 8 weeks was also seen (odds ratio, 1.98 [CI, 1.12 to 3.48]; P = 0.018). No difference was found in terms of the other secondary end points. LIMITATION Participation was restricted to patients who were malnourished, were able to drink oral supplements, and were living in long-term care institutions or receiving home care services. CONCLUSION Among malnourished patients with PU, 8 weeks of supplementation with an oral nutritional formula enriched with arginine, zinc, and antioxidants improved PU healing. PRIMARY FUNDING SOURCE Azienda Ospedaliera Universitaria Maggiore della Carità.
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Genome-wide association study of toxic metals and trace elements reveals novel associations.
Ng, E, Lind, PM, Lindgren, C, Ingelsson, E, Mahajan, A, Morris, A, Lind, L
Human molecular genetics. 2015;(16):4739-45
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The accumulation of toxic metals in the human body is influenced by exposure and mechanisms involved in metabolism, some of which may be under genetic control. This is the first genome-wide association study to investigate variants associated with whole blood levels of a range of toxic metals. Eleven toxic metals and trace elements (aluminium, cadmium, cobalt, copper, chromium, mercury, manganese, molybdenum, nickel, lead and zinc) were assayed in a cohort of 949 individuals using mass spectrometry. DNA samples were genotyped on the Infinium Omni Express bead microarray and imputed up to reference panels from the 1000 Genomes Project. Analyses revealed two regions associated with manganese level at genome-wide significance, mapping to 4q24 and 1q41. The lead single nucleotide polymorphism (SNP) in the 4q24 locus was rs13107325 (P-value = 5.1 × 10(-11), β = -0.77), located in an exon of SLC39A8, which encodes a protein involved in manganese and zinc transport. The lead SNP in the 1q41 locus is rs1776029 (P-value = 2.2 × 10(-14), β = -0.46). The SNP lies within the intronic region of SLC30A10, another transporter protein. Among other metals, the loci 6q14.1 and 3q26.32 were associated with cadmium and mercury levels (P = 1.4 × 10(-10), β = -1.2 and P = 1.8 × 10(-9), β = -1.8, respectively). Whole blood measurements of toxic metals are associated with genetic variants in metal transporter genes and others. This is relevant in inferring metabolic pathways of metals and identifying subsets of individuals who may be more susceptible to metal toxicity.
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Association of serum concentrations of magnesium and some trace elements with cardiometabolic risk factors and liver enzymes in adolescents: the CASPIAN-III Study.
Kelishadi, R, Ataei, E, Motlagh, ME, Yazdi, M, Tajaddini, MH, Heshmat, R, Ardalan, G
Biological trace element research. 2015;(1-2):97-102
Abstract
This study aims to investigate the association of serum concentrations of magnesium (Mg), selenium (Se), chromium (Cr), and copper (Cu) with cardiometabolic risk factors and liver functions in Iranian children and adolescents. This case-control study was conducted under a national surveillance program. It comprised 320 students, aged 10-18 years, in two groups of equal number with or without metabolic syndrome (MetS). Serum concentrations of Mg and abovementioned trace elements were measured by atomic absorption spectrophotometry. Median regression analysis and different models of logistic regression were used to determine the associations of these elements with cardiometabolic risk factors. In the MetS group, the median of Mg, Se, Cr, and Cu was lower or equal to controls. Mg had significant inverse association with some MetS components; however, the corresponding figure was stronger for the simultaneous association of Mg, Se, Cr, and Cu with MetS components. The binary logistic regression revealed that Mg was a significant protective factor against MetS (P = 0.0001). Likewise, by considering the simultaneous association of Mg, Se, Cr, and Cu with MetS, Se was a significant protective factor against MetS. The corresponding figures were not significant for Cr and Cu. Se and Cu had significant inverse association with liver enzymes. The protective role of Mg and Se against MetS and liver enzymes, as well as the associations of these elements with some cardiometabolic risk factors and liver enzymes in the pediatric age group should be considered in future preventive and interventional studies.
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Iron Supplementation in Iron-Replete and Nonanemic Pregnant Women in Tanzania: A Randomized Clinical Trial.
Etheredge, AJ, Premji, Z, Gunaratna, NS, Abioye, AI, Aboud, S, Duggan, C, Mongi, R, Meloney, L, Spiegelman, D, Roberts, D, et al
JAMA pediatrics. 2015;(10):947-55
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IMPORTANCE Anemia is common in pregnancy and increases the risk of adverse outcomes. Iron deficiency is a leading cause of anemia in sub-Saharan Africa, and iron supplementation is the standard of care during pregnancy; however, recent trials among children have raised concerns regarding the safety of iron supplementation in malaria-endemic regions. There is limited evidence on the safety of iron supplementation during pregnancy in these areas. OBJECTIVE To evaluate the safety and efficacy of iron supplementation during pregnancy in a malaria-endemic region. DESIGN, SETTING, AND PARTICIPANTS We conducted a randomized, double-blind, placebo-controlled clinical trial among pregnant women presenting for antenatal care in Dar es Salaam, Tanzania, from September 28, 2010, through October 4, 2012. Iron-replete, nonanemic women were eligible if they were uninfected with human immunodeficiency virus, primigravidae or secundigravidae, and at or before 27 weeks of gestation. Screening of 21,316 women continued until the target enrollment of 1500 was reached. Analyses followed the intent-to-treat principle and included all randomized participants. INTERVENTIONS Participants were randomized to receive 60 mg of iron or placebo, returning every 4 weeks for standard prenatal care, including malaria screening, prophylaxis with the combination of sulfadoxine and pyrimethamine, and treatment, as needed. MAIN OUTCOMES AND MEASURES The primary outcomes were placental malaria, maternal hemoglobin level at delivery, and birth weight. RESULTS Among 1500 study participants (750 randomized for each group), 731 in iron group and 738 in placebo group had known birth outcomes and 493 in iron group and 510 in placebo group had placental samples included in the analysis. Maternal characteristics were similar at baseline in the iron and placebo groups, and 1354 (91.7%) used malaria control measures. The risk of placental malaria was not increased by maternal iron supplementation (relative risk [RR], 1.03; 95% CI, 0.65-1.65), and iron supplementation did not significantly affect birth weight (3155 vs 3137 g, P = .89). Compared with placebo, iron supplementation significantly improved the mean increase from baseline to delivery for hemoglobin (0.1 vs -0.7 g/dL, P < .001) and serum ferritin (41.3 vs 11.3 µg/L, P < .001). Iron supplementation significantly decreased the risk of anemia at delivery by 40% (RR, 0.60; 95% CI, 0.51-0.71) but not severe anemia (RR, 0.68; 95% CI, 0.41-1.14). Iron supplementation significantly reduced the risk of maternal iron deficiency at delivery by 52% (RR, 0.48; 95% CI, 0.32-0.70) and the risk of iron deficiency anemia by 66% (RR, 0.34; 95% CI, 0.19-0.62). CONCLUSIONS AND RELEVANCE Prenatal iron supplementation among iron-replete, nonanemic women was not associated with an increased risk of placental malaria or other adverse events in the context of good malaria control. Participants receiving supplementation had improved hematologic and iron status at delivery compared with the placebo group. These findings provide support for continued administration of iron during pregnancy in malaria-endemic regions. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01119612.
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Universal iron supplementation: a simple and effective strategy to reduce anaemia among low-income, postpartum women.
Mitra, AK, Khoury, AJ
Public health nutrition. 2012;(3):546-53
Abstract
OBJECTIVE To reduce prevalence of anaemia in low-income postpartum women. DESIGN A randomised, non-blind clinical trial was conducted among 959 low-income, postpartum women in eleven clinics in Mississippi. The clinics were randomised to one of three treatment groups: (i) selective anaemia screening of high-risk women as recommended currently (control); (ii) universal anaemia screening and treatment of anaemic women (group I); and (iii) universal Fe supplementation of 65 mg/d for two months to all low-income women (group II). All study participants within each clinic received the same treatment. Women were followed up at 6 months after delivery. Hb was measured at baseline and at follow-up. The primary outcome variable was the proportion of women with anaemia after treatment. SETTING Eleven health clinics in Mississippi. SUBJECTS Low-income, postpartum women. RESULTS Baseline characteristics of the three study groups were compared using one-way ANOVA and an appropriate post hoc test for continuous variables and the χ2 test for categorical variables. Fifty-two per cent of postpartum women were anaemic (Hb < 12·0 g/dl) and the rate decreased to 33 % at 6 months after the intervention. Group II women, who received universal Fe supplementation, improved their Hb status significantly (P < 0·001) at 6 months postpartum compared with the other groups. Prevalence of anaemia was also significantly lower among group II women (22·5 %) compared with controls (34 %) and group I women (43 %; P < 0·001). CONCLUSIONS A universal Fe supplementation strategy was effective in reducing the prevalence of anaemia among low-income postpartum women.
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Effect of a vitamin/mineral supplement on children and adults with autism.
Adams, JB, Audhya, T, McDonough-Means, S, Rubin, RA, Quig, D, Geis, E, Gehn, E, Loresto, M, Mitchell, J, Atwood, S, et al
BMC pediatrics. 2011;:111
Abstract
BACKGROUND Vitamin/mineral supplements are among the most commonly used treatments for autism, but the research on their use for treating autism has been limited. METHOD This study is a randomized, double-blind, placebo-controlled three month vitamin/mineral treatment study. The study involved 141 children and adults with autism, and pre and post symptoms of autism were assessed. None of the participants had taken a vitamin/mineral supplement in the two months prior to the start of the study. For a subset of the participants (53 children ages 5-16) pre and post measurements of nutritional and metabolic status were also conducted. RESULTS The vitamin/mineral supplement was generally well-tolerated, and individually titrated to optimum benefit. Levels of many vitamins, minerals, and biomarkers improved/increased showing good compliance and absorption. Statistically significant improvements in metabolic status were many including: total sulfate (+17%, p = 0.001), S-adenosylmethionine (SAM; +6%, p = 0.003), reduced glutathione (+17%, p = 0.0008), ratio of oxidized glutathione to reduced glutathione (GSSG:GSH; -27%, p = 0.002), nitrotyrosine (-29%, p = 0.004), ATP (+25%, p = 0.000001), NADH (+28%, p = 0.0002), and NADPH (+30%, p = 0.001). Most of these metabolic biomarkers improved to normal or near-normal levels.The supplement group had significantly greater improvements than the placebo group on the Parental Global Impressions-Revised (PGI-R, Average Change, p = 0.008), and on the subscores for Hyperactivity (p = 0.003), Tantrumming (p = 0.009), Overall (p = 0.02), and Receptive Language (p = 0.03). For the other three assessment tools the difference between treatment group and placebo group was not statistically significant.Regression analysis revealed that the degree of improvement on the Average Change of the PGI-R was strongly associated with several biomarkers (adj. R2 = 0.61, p < 0.0005) with the initial levels of biotin and vitamin K being the most significant (p < 0.05); both biotin and vitamin K are made by beneficial intestinal flora. CONCLUSIONS Oral vitamin/mineral supplementation is beneficial in improving the nutritional and metabolic status of children with autism, including improvements in methylation, glutathione, oxidative stress, sulfation, ATP, NADH, and NADPH. The supplement group had significantly greater improvements than did the placebo group on the PGI-R Average Change. This suggests that a vitamin/mineral supplement is a reasonable adjunct therapy to consider for most children and adults with autism. CLINICAL TRIAL REGISTRATION NUMBER NCT01225198.