Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
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|ClinicalTrials.gov Identifier: NCT03188445|
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia of Pregnancy||Drug: Iron Isomaltoside 1000 Drug: ferrous fumarate with ascorbic acid||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy: a Randomised, Comparative, Open-label Trial|
|Actual Study Start Date :||July 11, 2017|
|Estimated Primary Completion Date :||August 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: IV administration
Iron isomaltoside (Monofer) Administered iv
Drug: Iron Isomaltoside 1000
Active Comparator: Oral administration
Ferrous fumarate with ascorbic acid Administered oral
Drug: ferrous fumarate with ascorbic acid
- The primary outcome measure is the achievement of an hemoglobin equal or above 11 g/dL [ Time Frame: from baseline to 18 weeks after treatment ]
- Achievement of an hemoglobin equal to or above 11 g/dL [ Time Frame: T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks ]
- Change in iron biomarkers [ Time Frame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03188445
|Contact: Lars Lykke Thomsen, MD||+45 firstname.lastname@example.org|
|Copenhagen, Sjaeland, Denmark|
|Study Chair:||Lars Lykke Thomsen, MD||Pharmacosmos A/S|