Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin

A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00802139

Enrollment

Registered

2008-12-04

Start date

2008-02-29

Completion date

2010-10-31

Last updated

2012-03-30

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

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency anemia, pregnant women with iron deficiency anemia

Brief summary

multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study

Interventions

DRUGvenoferrum(iron sucrose)

administer once weekly calculated quantity of Venoferrum® ampoules according to body weight and Hb level.

DRUGBolgre (Iron acetyl-transferase)

Twice daily administration with Bolgre® soln (one pouch per dosing which is equivalent to 40mg of iron) for 5 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 30\ 32nd weeks pregnant women aged over 18 years * Women who have Hb level of more than 10.0g/dL a week before study initiation * Patients who agree to participate in this study in writing

Exclusion criteria

* Patients who have participated in another clinical study in recent 3 months * Patients who are prone to acute hemorrhage during pregnancy * Patients who have shown intolerance to iron therapy * Hemolytic anemia, hemoglobinopathies (thalassemia, sickle cell) * Bleeding tendency, hypersplenism * Chronic heart failure, Class II-IV heart disease, uncontrolled arterial hypertension (DBP ≥ 115mmHg), deep vein thrombosis, thrombocytosis, chronic renal disease * Severe renal failure patients (2.5 times or more higher plasma creatinine level than high limit of normal state) * Patients with severe liver dysfunction (2.5 times or more higher AST or ALT than high limit of normal state) * Patients with doubled or more CK level than high limit of normal state * Patients who are regarded as ineligible for this study by investigator

Design outcomes

Primary

Measure	Time frame
Change of plasma hemoglobin level	5 week

Secondary

Measure	Time frame
Target Hb achievement rate(11g/dL), Transferrin saturation(%), Ferritin(ng/mL), TIBC(ug/dL), MCV(fl), MCH(pg) and change in reticulocyte counts	5 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026