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Heme-bound iron (Optifer) versus intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia

Heme-bound iron (Optifer) versus intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001483246
Enrollment
220
Registered
2018-09-04
Start date
2019-07-03
Completion date
2020-05-04
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pregnant women with pregnancy associated iron deficiency anemia and hemoglobin less than or equal 10 gm/dl (8-10 gm/dl) will included in this study to receive either Optifer tablets (Per Oral (PO) group) or intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia. Women in the per oral (PO) group will receive heme-bound iron Optifer (HIO) tablets twice daily (1 tablet morning and 1 tablet evening) not related to meals for more than or equal 3 months till hemoglobin level of 11-12 gm/dl then one tablet daily as maintenance dose. Women in the intravenous (IV) group will receive the calculated intravenous iron dose, which will be given over 6-8 sessions, in each session 200 mg of iron saccharate complex (Ferosac) will be diluted in normal saline and given by intravenous infusion over one hour every other day. The Optifer and intravenous iron (Ferosac) efficacy will checked by comparing the pre-treatment hemoglobin, ferritin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) and the primary outcome measures; the efficacy of the heme-bound iron Optifer (HIO) compared to intravenous iron (Ferosac) in treatment of pregnancy associated iron deficiency anemia.

Interventions

This comparative study designed to compare the efficacy and tolerability of the heme-bound iron Optifer (HIO) versus iron saccharate complex (Ferosac) in treatment of pregnancy associated iron deficiency anemia. Studied women will receive either heme-bound iron Optifer (HIO) tablets (Per Oral (PO) group) or intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia. The Optifer tablets contain 18 mg heme-bound iron. Each tablet

This comparative study designed to compare the efficacy and tolerability of the heme-bound iron Optifer (HIO) versus iron saccharate complex (Ferosac) in treatment of pregnancy associated iron deficiency anemia. Studied women will receive either heme-bound iron Optifer (HIO) tablets (Per Oral (PO) group) or intravenous iron saccharate (Ferosac), (Intravenous (IV) group) for correction of pregnancy associated iron deficiency anemia. The Optifer tablets contain 18 mg heme-bound iron. Each tablet of Optifer increases the serum iron by 3.15 mg and women in the Optifer group will receive two tablets twice daily 1 tablet morning and 1 tablet evening (according to manufacturer instructions) for at least equal or more than 3 months. Women in the intravenous group will receive the calculated intravenous iron dose according to the formula; total iron needed in mg = 2.4 × pre-pregnancy weight in kg × (target hemoglobin concentration - actual hemoglobin concentration) gm/dl + 500 mg. Twelve (12) gm/dl is the target hemoglobin concentration and 2.4 is a correction factor, while the 500 is the amount of stored iron in adult pregnant women. The calculated total intravenous iron dose will be given over 6-8 sessions, in each session 200 mg of iron saccharate complex will be diluted in normal saline and given by intravenous infusion over one hour every other day. The adherence to the intervention will be checked by the empty tablets package in the oral group and by the hospital admission records in the intravenous group. The adherence to treatment in intravenous group will be checked by the hospital admission records. This study is non-randomized study; the first half of enrolled women will receive oral iron Optifer and the second half of enrolled women will receive intravenous iron. In addition; women who will develop intolerance or gastric upset to oral iron Optifer will shifted to intravenous iron preparation.

Sponsors

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria includes; pregnant women more than or equal 20 years` old, 14-26 weeks` gestation, with hemoglobin less than or equal 10 gm/dl (8-10 gm/dl).

Exclusion criteria

Pregnant women with anemia other than iron deficiency anemia and/or received blood transfusion during current pregnancy will excluded from this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026