ferrous-succinate and Anemia--Iron-Deficiency

It remains uncertain whether vitamin C routinely used with oral iron supplements is essential for patients with iron deficiency anemia (IDA).. To compare the equivalence and assess the safety of oral iron supplements plus vitamin C or oral iron supplements alone in patients with IDA.. This single-center, open-label, equivalence randomized clinical trial was conducted from January 1, 2016, to December 30, 2017, in Huashan Hospital, Fudan University. Adult patients with newly diagnosed IDA were enrolled. Participants were randomly assigned (1:1) to the oral iron supplements plus vitamin C group or the oral iron supplements-only group. Data analysis was performed from March to December 2018.. Patients were randomized to receive a 100-mg oral iron tablet plus 200 mg of vitamin C or a 100-mg iron tablet alone every 8 hours daily for 3 months.. The primary outcome was the change in hemoglobin level from baseline to 2 weeks of treatment, and an equivalence margin of 1 g/dL in hemoglobin was chosen for the demonstration of comparable efficacy. Secondary outcomes included the change in the reticulocyte percentage after 2 weeks of treatment, the increase in hemoglobin level after 4 weeks of treatment, the increase in serum ferritin level after 8 weeks of treatment, and adverse events.. Among the 440 randomized patients (220 each in the oral iron supplements plus vitamin C group and iron-only group; 426 women [96.8%]; mean [SD] age, 38.3 [11.7] years), all were assessed for the primary outcome, and 432 (98.2%) completed the trial. From baseline to the 2-week follow-up, the mean (SD) change in hemoglobin level was 2.00 (1.08) g/dL in the oral iron supplements plus vitamin C group and 1.84 (0.97) g/dL in the oral iron supplements-only group (between-group difference, 0.16 g/dL; 95% CI, -0.03 to 0.35 g/dL), thus meeting the criteria for equivalence. The mean (SD) change in serum ferritin level from baseline to 8-week follow-up was 35.75 (11.52) ng/mL in the vitamin C plus iron group and 34.48 (9.50) ng/mL in the iron-only group (between-group difference, 1.27 ng/mL; 95% CI, -0.70 to 3.24 ng/mL; P = .21). There were no significant differences between the 2 groups regarding the rates of adverse events (46 [20.9%] vs 45 [20.5%]; difference, 0.4%; 95% CI, -6.7% to 8.5%; P = .82). No patient withdrew because of adverse events.. Among patients with IDA, oral iron supplements alone were equivalent to oral iron supplements plus vitamin C in improving hemoglobin recovery and iron absorption. These findings suggest that on-demand vitamin C supplements are not essential to take along with oral iron supplements for patients with IDA.. ClinicalTrials.gov Identifier: NCT02631668.

Topics: Adult; Anemia, Iron-Deficiency; Ascorbic Acid; Dietary Supplements; Drug Therapy, Combination; Female; Ferrous Compounds; Hemoglobins; Humans; Male; Middle Aged; Vitamins

Low birth weight infants are at risk for iron deficiency (ID). Most LBW infants have marginally low birth weight (MLBW, 2000-2500 g) and it is not known whether they benefit from iron supplements. The objective of this trial was to study the effects of iron supplementation in MLBW infants.. In a randomized controlled trial, we assigned 285 healthy, MLBW infants to receive iron supplements at a dose of 0 (placebo), 1, or 2 mg/kg per day between 6 weeks and 6 months of age. Hemoglobin levels, ferritin levels, transferrin saturation, mean cell volume, and transferrin receptor levels were analyzed at 6 months. Growth and morbidity were monitored.. Iron supplementation resulted in significant dose-dependent effects on hemoglobin and all iron status indicators at 6 months. The prevalence of ID at 6 months was 36% in the placebo group, 8.2% in the 1 mg/kg per day group, and 3.8% in the 2 mg/kg per day group (P<.001). The prevalence rates of ID anemia (IDA) were 9.9%, 2.7%, and 0%, respectively (P=.004). Among infants who were exclusively breastfed at 6 weeks, the prevalence of IDA was 18% in the placebo group. There were no significant differences between groups in growth or morbidity.. MLBW infants have relatively high risks of ID and IDA, especially if they are breastfed. Iron supplementation at 2 mg/kg per day from 6 weeks to 6 months reduces this risk effectively, with no short-term adverse effects on morbidity or growth.

Topics: Anemia, Iron-Deficiency; Breast Feeding; Double-Blind Method; Female; Ferrous Compounds; Hemoglobins; Humans; Infant; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Iron; Male; Transferrin

To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose.. One hundred and ninety-four patients on maintenance dialysis with the hemoglobin (Hb) level of 60 - 100 g/L and hematocrit (Hct) of 18% - 30% were randomly divided into 2 sex, age, duration of dialysis, weekly erythropoietin dosage, and hematological parameters-matched groups: intravenous iron sucrose group (n = 102) and oral medication group (n = 92). The intravenous iron sucrose group were sub-divided into 2 subgroups: (1) hemodialysis (HD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 100 mg once a week for a further 8 weeks, and (2) peritoneal dialysis (PD) subgroup receiving intravenous iron sucrose 200 mg once a week for 4 weeks and then 200 mg once every other week for a further 8 weeks. The oral medication group received ferrous succinate 200 mg tid for 12 weeks. The levels of serum ferritin (SF), transferrin saturation (TSAT), Hb, and Hct were examined before treatment and 4, 8, and 12 weeks after treatment.. (1) Compared with baseline levels, the levels of Hb, Hct, SF, and TSAT significantly increased 2 weeks after treatment in the intravenous iron sucrose group, and 4 weeks after treatment in the oral medication group (all P < 0.05). (2) The Hb, Hct, SF, and TSAT levels 4, 6, 8, and 12 weeks after treatment of the 2 intravenous iron sucrose subgroups were all significantly higher than those of the oral medication group (all P < 0.05). (3) The Hb, Hct, SF, and TSAT levels 12 weeks after treatment 6, 8, and 12 weeks after treatment were not significantly different from those 4 weeks after treatment in the intravenous iron sucrose group (all P > 0.05). (4) The response rate of the intravenous iron sucrose group was 95.09%, significantly higher than that of the oral medication group (55.44%, P < 0.05). (5) The mean EPO doses 6, 8 and 12 weeks after treatment of the intravenous iron sucrose group were significantly lower than that before treatment and those of the oral medication group (all P < 0.05). (6) The Hb, Hct, SF, and TSAT levels maintained stable during the period 6, 8, and 12 weeks after treatment in the intravenous iron sucrose group despite the decrease in dose and frequency. (7) The Hb, Hct, SF, and TSAT levels were significantly higher in the intravenous PD subgroup than in the intravenous HD subgroup. (8) No adverse event was found in the intravenous iron sucrose group, and adverse gastrointestinal effects occurred in 12 patients of the oral medication group. (9) After 12 weeks, the cost of EPO + intravenous iron sucrose was significantly higher than that of EPO + ferrous succinate.. Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated. Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO. However, the total cost of intravenous iron treatment is relatively high.

Topics: Adult; Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferrous Compounds; Glucaric Acid; Humans; Injections, Intravenous; Male; Middle Aged; Prospective Studies; Renal Dialysis

To elucidate the influences of H pylori infection on oral iron treatment for iron deficiency anemia (IDA).. A total of 86 patients were divided into two groups: group A, receiving ferrous succinate combined with triple therapy for H pylori eradication, and group B (control), treated with ferrous succinate only. During treatment of IDA, dynamic changes in hemoglobin (Hb) level, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), serum iron (SI), and serum ferritin (SF) were compared between the groups.. Hb was slightly higher in group A at d 14 after the start of triple therapy for H pylori eradication (P > 0.05). After the therapy, the increase of Hb in group A became significantly faster than that in group B (P < 0.05). At d 56, the mean Hb in group A returned to the normal level, however, in group B, it was lower than that in group A (P < 0.05) although it had also increased compared with that before oral iron treatment. The MCV and MCH in group A recovered to the normal level, and were much higher than those in group B (P < 0.05) at d 21. In Group B, the MCV and MCH remained at lower than normal levels until d 42 after the start of therapy. And then, they reached a plateau in both groups and the differences disappeared (P > 0.05). The SF in group A was higher than that in group B (P < 0.05) 28 d after the treatment and its improvement was quicker in group A (P < 0.05) , and the difference between the two groups was even more significant (P < 0.01) at d 56. The SI in group A was higher than that in group B (P < 0.05) at d 14 and this persisted until d 56 when the follow-up of this research was finished.. Treatment of H pylori can enhance the efficacy of ferrous succinate therapy in IDA patients with H pylori-positive chronic gastritis.

Topics: Adolescent; Adult; Aged; Amoxicillin; Anemia, Iron-Deficiency; Anti-Infective Agents; Chronic Disease; Drug Therapy, Combination; Erythrocyte Indices; Female; Ferritins; Ferrous Compounds; Gastritis; Helicobacter Infections; Helicobacter pylori; Hemoglobins; Humans; Iron; Male; Metronidazole; Middle Aged; Organometallic Compounds; Risk Factors

Topics: Anemia; Anemia, Hypochromic; Anemia, Iron-Deficiency; Ferrous Compounds; Humans; Iron; Succinates; Tablets