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Efficacy and safety of ferrous asparto glycinate in the management of iron deficiency anaemia in pregnant women.
Kamdi, SP, Palkar, PJ
Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology. 2015;(1):4-8
Abstract
The aim of the present investigation was to compare the efficacy and safety of oral ferrous asparto glycinate and ferrous ascorbate in pregnant women with iron deficiency anaemia (IDA). We performed a double blind, prospective, randomised, multicentre, parallel group comparative clinical study at three different centres in India. A total of 73 pregnant women at 12-26 weeks' gestation were divided into two arms. While one group received ferrous ascorbate, another group was treated with ferrous asparto glycinate for a period of 28 days. The mean rise in haemoglobin and ferritin levels on day 14 and 28 was evaluated. At both time points, significantly higher levels of haemoglobin and ferritin were noticed with ferrous asparto glycinate treatment as compared with ferrous ascorbate. Our results showed that ferrous asparto glycinate is an effective iron-amino acid chelate in the management of IDA in pregnant women as compared with ferrous ascorbate. Nevertheless, additional large scale prospective, randomised trials are warranted to confirm the findings of the present efficacy trial, and also to find out the anaemia eradication rate.
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Effects of iron supplements and perinatal factors on fetal hemoglobin disappearance in LBW infants.
Berglund, SK, Lindberg, J, Westrup, B, Domellöf, M
Pediatric research. 2014;(5):477-82
Abstract
BACKGROUND The homeostatic mechanisms of iron metabolism and erythropoiesis in infants are unclear. Infants synthesize both fetal hemoglobin (HbF) and adult hemoglobin (HbA), and it is not known how the hemoglobin switch is regulated. We hypothesized that iron supplements to infants affect the disappearance of HbF. METHODS We randomized 285 low-birth-weight infants (2,000-2,500 g) into three intervention groups receiving 0, 1, or 2 mg/kg/d of iron supplements from 6 wk to 6 mo of age. In the present secondary analysis, we analyzed iron status, total hemoglobin (Hb), and HbF fraction at 6 wk, 12 wk, and at 6 mo and calculated absolute levels of HbF. RESULTS We observed dose-dependent increased levels of Hb in iron-supplemented groups at 6 mo of age. However, for absolute HbF concentration, there was no similar effect of intervention. Mean (SD) HbF was 81.2 (16.8), 37.0 (13.8), and 8.1 (5.6) g/l at 6 wk, 12 wk, and 6 mo, respectively, similar in all groups. In linear regression analyses, postconceptional age turned out as the major predictor of HbF, independent of gestational age at birth. CONCLUSION Our hypothesis was rejected. Instead, we confirmed a close correlation to postconceptional age, supporting a genetically programmed switch, insensitive to most environmental factors including birth.
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The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.
Macdougall, IC, Bock, A, Carrera, F, Eckardt, KU, Gaillard, C, Van Wyck, D, Roubert, B, Cushway, T, Roger, SD, ,
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 2014;(4):843-50
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Abstract
BACKGROUND Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). METHODS FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL). RESULTS The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013. DISCUSSION FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.
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IRON-HF study: a randomized trial to assess the effects of iron in heart failure patients with anemia.
Beck-da-Silva, L, Piardi, D, Soder, S, Rohde, LE, Pereira-Barretto, AC, de Albuquerque, D, Bocchi, E, Vilas-Boas, F, Moura, LZ, Montera, MW, et al
International journal of cardiology. 2013;(4):3439-42
Abstract
BACKGROUND Anemia in heart failure patients and has been associated with increased morbi-mortality. Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous (i.v.) iron. However, the effect of i.v. or oral (p.o.) iron supplementation alone in heart failure patients with anemia was virtually unknown. AIM: To compare, in a double-blind design, the effects of i.v. iron versus p.o. iron in anemic heart failure patients. METHODS IRON-HF study was a multicenter, investigator initiated, randomized, double-blind, placebo controlled trial that enrolled anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels. Interventions were Iron Sucrose i.v. 200 mg, once a week, for 5 weeks, ferrous sulfate 200 mg p.o. TID, for 8 weeks, or placebo. Primary endpoint was variation of peak oxygen consumption (peak VO2) assessed by ergospirometry over 3 month follow-up. RESULTS Eighteen patients had full follow-up data. There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v. iron group. There was no increment in peak VO2 in the p.o. iron group. Patients' ferritin and TSat increased significantly in both treated groups. Hemoglobin increased similarly in all groups. CONCLUSION I.v. iron seems to be superior in improving functional capacity of heart failure patients. However, correction of anemia seems to be at least similar between p.o. iron and i.v. iron supplementation.
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A 12-week randomised study comparing intravenous iron sucrose versus oral ferrous sulphate for treatment of postpartum anemia.
Westad, S, Backe, B, Salvesen, KA, Nakling, J, Økland, I, Borthen, I, Rognerud Jensen, OH, Kolås, T, Løkvik, B, Smedvig, E
Acta obstetricia et gynecologica Scandinavica. 2008;(9):916-23
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OBJECTIVE To analyze the effect of intravenous ferrous sucrose compared with oral ferrous sulphate on hematological parameters and quality of life in women with postpartum anemia. DESIGN Open randomised controlled trial. SETTING Multicentre study comprising five obstetrical departments in Norway. POPULATION Hundred and twenty-eight postpartum women with hemorrhagic anemia (Hb between 6.5 g/100 ml and 8.5 g/100 ml). The intervention group (59 women) received 600 mg iron sucrose intravenously followed by 200 mg iron sulphate daily from week 5. The control group (70 women) were given 200 mg iron sulphate daily. METHODS Randomisation and start of treatment occurred within 48 hours of the delivery. Participants were followed up at 4, 8 and 12 weeks. MAIN OUTCOME MEASURES Hemoglobin, ferritin and quality of life assessed with the Medical Outcomes Study Short Form 36 (SF-36) and the Fatigue Scale. RESULTS After 4 weeks the mean hemoglobin values in both groups were similar (11.9 g/100ml vs. 12.3g/100ml, p=0.89). The mean serum ferritin value after 4 weeks was significantly higher in the intervention group with 13.7 microg/L vs. 4.2 microg/L in the control group (p<0.001). At 8 and 12 weeks the hematological parameters were similar. The total fatigue score was significantly improved in the intervention group at week 4, 8 and 12, whereas SF-36 scores did not differ. CONCLUSION Women who received 600 mg intravenous iron sucrose followed by standard oral iron after four weeks, replenished their iron stores more rapidly and had a more favorable development of the fatigue score indicating improved quality of life.
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A randomised placebo-controlled trial to determine the effect of iron supplementation on pregnancy outcome in pregnant women with haemoglobin > or = 13.2 g/dl.
Ziaei, S, Norrozi, M, Faghihzadeh, S, Jafarbegloo, E
BJOG : an international journal of obstetrics and gynaecology. 2007;(6):684-8
Abstract
OBJECTIVE To study the effect of iron supplementation on pregnancy outcome in pregnant women with haemoglobin (Hb) > or = 13.2 g/dl. DESIGN A randomised, double-blind, placebo-controlled trial. SETTING Routine health services. POPULATION Seven hundred and twenty-seven pregnant women with Hb > or = 13.2 g/dl in the early stage of the second trimester. METHODS Each woman took one ferrous sulphate [DOSAGE ERROR CORRECTED] tablet (150 g tablet, containing 50 mg of elemental iron) [DOSAGE ERROR CORRECTED] daily in the case group (n = 370) or placebo in the control group (n = 357) throughout pregnancy. MAIN OUTCOME MEASURES Pregnancy outcome. RESULTS While there were no significant differences in demographic and obstetric characteristics between the two groups before any intervention, small-for-gestational-age birth rate and the number of women with hypertension disorder increased significantly in the case group in comparison with the control group (57 [15.7%] versus 36 [10.3%], P = 0.035, 10 [2.7%] versus 3 [8%], P = 0.05, respectively). CONCLUSIONS Our finding proves that routine iron supplementation in nonanaemic women is not rational and may be harmful.
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Iron supplements reduce erythrocyte copper-zinc superoxide dismutase activity in term, breastfed infants.
Domellöf, M, Dewey, KG, Cohen, RJ, Lönnerdal, B, Hernell, O
Acta paediatrica (Oslo, Norway : 1992). 2005;(11):1578-82
Abstract
AIM: To investigate whether iron supplements compromise copper status in infants. METHODS 214 healthy, term, breastfed Swedish and Honduran infants were randomized to (1) iron supplements (1 mg/kg/d) from 4-9 mo of age, (2) iron supplements from 6-9 mo, or (3) placebo. Blood samples were obtained at 4, 6, and 9 mo and analyzed for plasma copper (p-Cu) and, at 9 mo, for copper/zinc-dependent superoxide dismutase (CuZn-SOD) activity. RESULTS P-Cu increased with infant age. At 9 mo, Honduran infants had significantly higher p-Cu (1.40+/-0.29 vs 1.09+/-0.22 mg/l, p<0.001) and CuZn-SOD activity (1.09+/-0.29 vs 0.93+/-0.21 U/mg Hb, p<0.001) than Swedish infants. Infants receiving iron supplements from 4-9 mo had significantly lower CuZn-SOD at 9 mo of age (0.95+/-0.27 vs 1.08+/-0.24 U/mg Hb, p=0.023) than those receiving placebo. CONCLUSION There is a physiologic increase in p-Cu during the first 9 mo of life. Differences in copper status between Swedish and Honduran infants may be due to genetic or nutritional differences. Iron supplementation decreases CuZn-SOD activity, probably due to a negative effect on copper status. Possible clinical implications remain to be elucidated.
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Elective coronary and valve surgery without blood transfusion in patients treated with recombinant human erythropoietin (epoetin-alpha).
Podestà, A, Carmagnini, E, Parodi, E, Dottori, V, Crivellari, R, Barberis, L, Audo, A, Lijoi, A, Passerone, G
Minerva cardioangiologica. 2000;(11):341-7
Abstract
BACKGROUND This study evaluates the real effectiveness of epoetin-alpha associated with ferrous sulphate, in reducing blood transfusion in patients undergoing elective open heart surgery not treated with autologous donation. METHODS Sixty patients had been divided into 2 groups: group A (30 patients) treated with 525 mg ferrous sulphate three time a day per os for 3 weeks; group B (30 patients) treated with epoetin-alpha 10,000 UI twice a week and 525 mg ferrous sulphate 3 times a day. Grouping of patients has been randomized. In both groups hemoglobin, hematocrit, reticulocytes, iron values, ferritine, transferrine, and serological values, have been evaluated sequentially before treatment, before surgery, day of operation, 1st, 2nd, 3rd, 7th postoperative days and at discharge. RESULTS In group A 86% patients needed blood transfusion (26 out of 30); in group B only 3% of patients needed blood transfusion (1 patient). One year follow up didn't show side effects related to epoetin-alpha. CONCLUSIONS This study confirms the real effectiveness of epoetin-alpha in reducing the postoperative need for homologous blood transfusion. No side effects due to epoetin-alpha treatment have been proved. The conclusion is drawn that epoetin-alpha can be used as an alternative to blood transfusion or in association with predeposit and in the treatment of basal anemia.