Aim: The main objective of this trial was to compare the therapeutic efficacy, gastrointestinal and systemic tolerability as well as compliance on oral medicinal iron consumption and total related drugs costs between sustained released ferrous sulphate (SRFS) oral capsules and soft gelatinous capsules of non-ionic ferric (Fe+3) polymaltose complex (IPC) in treating gestational iron deficiency anemia (GIDA) in second (2nd) and early third (3rd) trimester.
Patients and Methods: This prospective, open-label, randomized, parallel group, concealed allocation, controlled, multicenter superiority trial was conducted at Benha University Hospital (BUH) and two private clinics in El-Qalubia, Egypt, from October 2016 to December 2017. We screened 500 pregnant women, 310 women were eligible and consented to participate in GIDA trial. All women included were had typical mild or moderate iron deficiency anemia (IDA) as their hemoglobin (HB), and serum ferritin (SF) was 10.5 or 11 to 8 gm/dl and 15 ng/ml respectively. 155 women were allocated to either consume 100mg elemental iron (EI) of dried SRFS (60 capsules of ferroful® / four weeks) in the SRFS arm or 100 mg EI of IPC (28Haemojet® capsules /4weeks) in IPC arm. Main outcomes were the change () in HB and SF at 4 weeks (T1), 8 weeks (T2), 12 weeks (T3) from baseline levels (T0) as well as incidence of gastrointestinal and systemic adverse side events (ASE) of consumed oral iron capsules and women compliance on drug intakes in addition to direct and indirect drug costs.
Results : 298 women started oral iron intake , 150 in SRFS arm and 148 in IPC arm, while at the end of study period (12 weeks), 20 (12.9%) women in SRFS versus 4 (2.6%) in IPC had severe ASE and stopped consumption of oral iron ( pp 10.3% at 95% C.I of 4.44, 16.68, P = 0.0004). At any follow up periods T1, T2, T3 the changes in HB were significantly higher in IPC group (P = 0.0001, P = 0.0064, P = 0.012) and changes in SF between T3 and T0 was (58.11 32.34 in SRFS vs 69.63 13.61 with 95% CI of -11.52 (-5.97, -17.06, P = 0.0001). Also percentage of women who consumed 75% of oral iron capsules / 4 weeks were significantly higher in IPC arm than SRFS arm P = 0.006, P =0.040, P = 0.007. Moreover, the total costs of direct and indirect used drugs were significantly less in IPC arm than SRFS group at T1, T2, T3(P < 0.0001, P < 0.0001, P < 0.0001). No severe sequels were noted in pregnancy outcomes could be attributed to used medicinal oral iron.
Conclusion: Oral non - ionic ferric (Fe+3) iron polymaltose complex was more effective, more tolerable as well as women were more complaint on its consumption and its total costs were lower than sustained released ferrous sulfate dried capsules in treating mild and moderate gestational iron deficiency in second and early third trimesters.
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