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Impact of iron fortification on anaemia and iron deficiency among pre-school children living in Rural Ghana.
Tchum, SK, Arthur, FK, Adu, B, Sakyi, SA, Abubakar, LA, Atibilla, D, Amenga-Etego, S, Oppong, FB, Dzabeng, F, Amoani, B, et al
PloS one. 2021;(2):e0246362
Abstract
Anaemia in young sub-Saharan African children may be due to the double burden of malaria and iron deficiency. Primary analysis of a double-blind, cluster randomized trial of iron containing micronutrient powder supplementation in Ghanaian children aged 6 to 35 months found no difference in malaria risk between intervention and placebo groups. Here, we performed a secondary analysis of the trial data to assess the impact of long-term prophylactic iron fortificant on the risk of iron deficiency and anaemia in trial subjects. This population-based randomized-cluster trial involved 1958 children aged between 6 to 35 months, identified at home and able to eat semi-solid foods. The intervention group (n = 967) received a daily dose containing 12.5 mg elemental iron (as ferrous fumarate), vitamin A (400 μg), ascorbic acid (30 mg) and zinc (5 mg). The placebo group (n = 991) received a similar micronutrient powder but without iron. Micronutrient powder was provided daily to both groups for 5 months. At baseline and endline, health assessment questionnaires were administered and blood samples collected for analysis. The two groups had similar baseline anthropometry, anaemia, iron status, demographic characteristics, and dietary intakes (p > 0.05). Of the 1904 (97.2%) children who remained at the end of the intervention, the intervention group had significantly higher haemoglobin (p = 0.0001) and serum ferritin (p = 0.0002) levels than the placebo group. Soluble transferrin receptor levels were more saturated among children from the iron group compared to non-iron group (p = 0.012). Anaemia status in the iron group improved compared to the placebo group (p = 0.03). Continued long-term routine use of micronutrient powder containing prophylactic iron reduced anaemia, iron deficiency and iron deficiency anaemia among pre-school children living in rural Ghana's malaria endemic area.
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The effect of selenium and zinc on CD4(+) count and opportunistic infections in HIV/AIDS patients: a randomized double blind trial.
Hadadi, A, Ostovar, A, Edalat Noor, B, Rasoolinejad, M, Haji Abdolbaghi, M, Yousefi, S, Khalili, H, Manshoori, G, Khashayar, P, Alipour, Z, et al
Acta clinica Belgica. 2020;(3):170-176
Abstract
Objectives: We assessed the effect of selenium and zinc supplementation on CD4 cell count and the risk of developing opportunistic infections.Methods: In a double blind clinical trial, 146 HIV(+) patients receiving combination antiretroviral therapy with CD4(+) >200/cubic millimeter were screened for comorbidities and opportunistic infections, and randomized to receive daily selenium (200 µg), zinc (50 mg) or placebo for 6 months, before a 3-month follow-up period. CD4 cell counts were measured in the 3th, 6th and 9th months. The serum selenium and zinc were measured in the 6th month. The incidence of opportunistic infection was assessed monthly for 6 months and at the end of the 9th month.Results: The final incidence of supplement deficiency for placebo, zinc and selenium were 46.7%, 44.7% and 50.0%, respectively. Overall compliance with supplementation was 99.42%. Although the changes from baseline were not statistically significant, zinc supplementation was significantly associated with reduced risk of opportunistic infections.Conclusion: Development of the opportunistic infections after zinc supplementation significantly decreased; however, significant improvement in CD4 count was not observed in this group.
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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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Infant Iron Deficiency and Iron Supplementation Predict Adolescent Internalizing, Externalizing, and Social Problems.
Doom, JR, Richards, B, Caballero, G, Delva, J, Gahagan, S, Lozoff, B
The Journal of pediatrics. 2018;:199-205.e2
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Abstract
OBJECTIVE To evaluate associations between iron supplementation and iron deficiency in infancy and internalizing, externalizing, and social problems in adolescence. STUDY DESIGN The study is a follow-up of infants as adolescents from working-class communities around Santiago, Chile who participated in a preventive trial of iron supplementation at 6 months of age. Inclusionary criteria included birth weight ≥3.0 kg, healthy singleton term birth, vaginal delivery, and a stable caregiver. Iron status was assessed at 12 and 18 months of age. At 11-17 years of age, internalizing, externalizing, and social problems were reported by 1018 adolescents with the Youth Self Report and by parents with the Child Behavior Checklist. RESULTS Adolescents who received iron supplementation in infancy had greater self-reported attention-deficit/hyperactivity disorder but lower parent-reported conduct disorder symptoms than those who did not (Ps < .05). Iron deficiency with or without anemia at 12 or 18 months of age predicted greater adolescent behavior problems compared with iron sufficiency: more adolescent-reported anxiety and social problems, and parent-reported social, post-traumatic stress disorder, attention-deficit/hyperactivity disorder, oppositional defiant, conduct, aggression, and rule breaking problems (Ps < .05). The threshold was iron deficiency with or without anemia for each of these outcomes. CONCLUSIONS Iron deficiency with or without anemia in infancy was associated with increased internalizing, externalizing, and social problems in adolescence.
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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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Trace Element Alterations in the Hair of Diabetic and Obese Women.
Fatani, SH, Saleh, SA, Adly, HM, Abdulkhaliq, AA
Biological trace element research. 2016;(1):32-39
Abstract
Alterations in the trace element content can induce metabolic disorders as these elements are involved in the regulation of metabolism. Obesity increases the likelihood of various diseases, particularly cardiovascular disease and type 2 diabetes, and is more prevalent in Saudi Arabia, especially in women. This study explored the potential of alterations in hair trace elements as long-term markers in diabetic and/or obese Saudi females. In total, 65 diabetic obese women, 47 non-diabetic obese women, and 70 normal-weight women were recruited. Clinical and familial history and anthropometric variables were recorded. Hair Se, Zn, Cu, Mn, and Fe levels were analyzed. Fasting blood sugar (FBS), glycated hemoglobin (HbA1c), and lipid profile were analyzed. Our findings revealed a marked decrease of hair Zn, Mn, and Fe and elevated Se and Cu levels in obese women. In addition, Zn and Fe levels were decreased in diabetic women. Thus, the metabolic distress occurring in obesity and hyperglycemia may affect trace element status by increasing the excretion and decreasing the bioavailability of trace elements or redistributing them among various pools. Hair trace elements can serve as important long-term markers for metabolic disorders; however, larger prospective studies are warranted to validate their diagnostic and follow-up utilities.
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A double blind randomised controlled trial comparing standard dose of iron supplementation for pregnant women with two screen-and-treat approaches using hepcidin as a biomarker for ready and safe to receive iron.
Bah, A, Wegmuller, R, Cerami, C, Kendall, L, Pasricha, SR, Moore, SE, Prentice, AM
BMC pregnancy and childbirth. 2016;(1):157
Abstract
BACKGROUND Until recently, WHO recommended daily iron supplementation for all pregnant women (60 mg/d iron combined with 400ug/d folic acid) where anaemia rates exceeded 40 %. Recent studies indicate that this may pose a risk to pregnant women. Therefore, there is a need to explore screen-and-treat options to minimise iron exposure during pregnancy using an overall lower dosage of iron that would achieve equivalent results as being currently recommended by the WHO. However, there is a lack of agreement on how to best assess iron deficiency when infections are prevalent. Here, we test the use of hepcidin a peptide hormone and key regulator of iron metabolism, as a potential index for 'safe and ready to receive' iron. DESIGN/METHODS This is a 3-arm randomised-controlled proof-of-concept trial. We will test the hypothesis that a screen-and-treat approach to iron supplementation using a pre-determined hepcidin cut-off value of <2.5 ng/ml will achieve similar efficacy in preventing iron deficiency and anaemia at a lower iron dose and hence will improve safety. A sample of 462 pregnant women in rural Gambia will be randomly assigned to receive: a) UNU/UNICEF/WHO international multiple micronutrient preparation (UNIMMAP) containing 60 mg/d iron (reference arm); b) UNIMMAP containing 60 mg/d iron but based on a weekly hepcidin screening indicating if iron can be given for the next 7 days or not; c) or UNIMMAP containing 30 mg/d iron as in (b) for 12 weeks in rural Gambia. The study will test if the screen-and-treat approach is non-inferior to the reference arm using the primary endpoint of haemoglobin levels at a non-inferiority margin of 0.5 g/dl. Secondary outcomes of adverse effects, compliance and the impact of iron supplementation on susceptibility to infections will also be assessed. DISCUSSION This trial is expected to contribute towards minimising the exposure of pregnant women to iron that may not be needed and therefore potentially harmful. If the evidence in this study shows that the overall lower dosage of iron is non-inferior to 60 mg/day iron, this may help decrease side-effects, improve compliance and increase safety. The potential for the use of hepcidin for a simple point-of-care (PoC) diagnostic for when it is most safe and effective to give iron may improve maternal health outcomes. TRIAL REGISTRATION ISRCTN21955180.
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An optimized multivitamin supplement lowers the number of vitamin and mineral deficiencies three years after Roux-en-Y gastric bypass: a cohort study.
Homan, J, Schijns, W, Aarts, EO, van Laarhoven, CJHM, Janssen, IMC, Berends, FJ
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2016;(3):659-667
Abstract
BACKGROUND Vitamin and mineral deficiencies are common after Roux-en-Y gastric bypass (RYGB) surgery. In particular, inadequate serum concentrations of ferritin and vitamin B12 have been found in 11% and 23% (respectively) of patients using a standard multivitamin supplement (sMVS) 1 year after RYGB. OBJECTIVE To evaluate the effectiveness and safety of Weight Loss Surgery (WLS) Forte® (a pharmaceutical-grade, optimized multivitamin supplement) compared with an sMVS and a control group (nonuser) 3 years after RYGB. SETTING General hospital specialized in bariatric surgery. METHODS A follow-up cohort study of a triple-blind randomized, controlled clinical trial. RESULTS At baseline 148 patients were enrolled (74 [50%] in the sMVS group and 74 [50%] in the WLS Forte group). After a mean follow-up of 36 months, 11 (7%) patients were lost to follow-up, of whom 2 were secondary to death. At the end of the study, 11 (17%) patients in the WLS Forte and 17 (24%) in the sMVS group stopped using a supplement. In addition, 64 (47%) patients were using WLS Forte and 45 (33%) patients a sMVS. Patient characteristics and follow-up length were comparable between the groups. Significantly more patients were diagnosed with anemia (16% versus 3% [P = .021]), a ferritin deficiency (14% versus 3% [P = .043]), and a zinc deficiency (8% versus 0% [P = .033]) in the sMVS group compared with WLS Forte. Five patients developed a vitamin B12 deficiency while using WLS Forte, versus 15 of sMVS users (P = .001). No adverse events occurred that were related to supplement use. CONCLUSION At 3 years postoperative of RYGB, an optimized multivitamin supplement (WLS Forte) was more effective in reducing anemia and ferritin, vitamin B12, and zinc deficiencies compared with a standard supplement and control.