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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
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

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

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia of Pregnancy Drug: Iron Isomaltoside 1000 Drug: ferrous fumarate with ascorbic acid Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IV administration
Iron isomaltoside (Monofer) Administered iv
Drug: Iron Isomaltoside 1000
Administered iv
Active Comparator: Oral administration
Ferrous fumarate with ascorbic acid Administered oral
Drug: ferrous fumarate with ascorbic acid
Oral administration



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in iron biomarkers [ Time Frame: From baseline to T=3 weeks, T=6 weeks, T=12 weeks, and T=18 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

A subject will be eligible for inclusion in the trial if she fulfils the following criteria:

  1. Women aged ≥18 years
  2. Pregnancy at GA 14+0 - 19+0
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged ≥18 years
  2. Pregnancy at GA 14+0 - 19+0
  3. Ferritin <30 μg/L after 4 weeks of standard treatment in a clinical setting
  4. Willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form

Exclusion Criteria:

  1. History of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
  2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  3. Drug hypersensitivity (i.e. previous hypersensitivity to IV iron)
  4. Known hypersensitivity to any excipients in the investigational drug products
  5. History of active asthma within the last 5 years
  6. History of multiple allergies
  7. Known decompensated liver cirrhosis or active hepatitis
  8. Active acute or chronic infections (assessed by clinical judgement)
  9. Rheumatoid arthritis with symptoms or signs of active inflammation
  10. Treated with IV iron products or blood transfusion within 4 weeks prior to inclusion
  11. Treated with erythropoietin (EPO) within 4 weeks prior to inclusion
  12. Participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion
  13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial
  14. Meeting RBC-transfusion criteria (Hb ≤6.9 g/dL= 4.3 mmol/L with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an Hb ≤6.4 g/dL (4.0 mmol/L) without intolerable symptoms of anaemia)
  15. Multiple pregnancies
  16. Inability to read and understand the Danish language

Information from the National Library of Medicine

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


Contacts
Contact: Lars Lykke Thomsen, MD +45 59485959 info@pharmacosmos.com

Locations
Denmark
Copenhagen Recruiting
Copenhagen, Sjaeland, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
Investigators
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03188445     History of Changes
Other Study ID Numbers: P-Monofer-PREG-01
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferrous fumarate
Ascorbic Acid
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Hematinics