NCT03188445

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.

Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

Detailed description

Iron deficiency (ID) in pregnant women can cause iron deficiency anaemia (IDA). ID is defined by low iron stores, measured by a low level of s-ferritin. Iron is essential for the synthesis of haemoglobin (Hb). Anaemia is defined by a low Hb level (\<11.0 g/dL in 1st trimester, \<10.5 g/dL in 2nd, and \<10.5 - 11.0 g/dL in 3rd trimesters). In Danish pregnant women, who do not take iron supplementation approximately 50 % have ID and 21 % have IDA. According to WHO anaemia, defined as Hb \<11.0 g/dL, regardless the cause is estimated to occur in 24 % of Danish pregnant women. This trial is designed to evaluate and compare the effect of IV iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of IDA in pregnant women after 4 weeks of standard treatment.

Conditions

• Iron Deficiency Anemia of Pregnancy

Interventions

Type	Name	Description
DRUG	Iron Isomaltoside 1000	Administered iv
DRUG	ferrous fumarate with ascorbic acid	Oral administration

Timeline

• Start date: 2017-07-11
• Primary completion: 2020-06-26
• Completion: 2020-08-18
• First posted: 2017-06-15
• Last updated: 2020-11-13

Locations

1 site across 1 country: Denmark