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 (Δ) 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 (Δ 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 Δ 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. |
