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 : December 18, 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 :||December 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|