Comparative study of the efficacy and tolerability of iron polymaltose complex film-coated tablets with folic acid (Maltofer® Fol film-coated tablets) compared to a generic iron sulphate product in pregnant women with iron-deficiency anaemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 423

Inclusion Criteria

• Patients of 18 years and above with iron deficiency anaemia (haemoglobin [Hb] <11 g/dL and ferritin =30 µg/L).
• Mean corpuscular volume (MCV) < 100 fL.
• Gestational weeks 15–23. Patients will be stratified according to their gestational age at inclusion in the following categories: 15-17, 18-20 and 21-23.
• Signed informed consent.
• Patient is willing and able to comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Iron overload (e.g., haemochromatosis, haemosiderosis).
• Disturbances in iron utilisation (e.g., lead anaemia, sidero achrestic anaemia, thalassaemia).
• Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia).
• Anaemia related to blood loss, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
• Known hypersensitivity to iron polymaltose complex film-coated tablets (Maltofer® Fol film-coated tablets) or to iron sulphate or to any excipients.
• Participation in another clinical study during the study and 4 weeks prior to the study.
• Preeclampsia.
• Acute infectious diseases, parasitosis.
• Tested positive for human immunodeficiency virus (HIV) or hepatitis B surface (HBs) antigen as confirmed by prior assessment at beginning of pregnancy (if prior assessments are not available, tests for HIV and HBs have to be performed at screening).
• History of alcohol or drug abuse.
• Non-responder to oral iron products.
• Severe diseases of liver, kidney, cardiovascular system, gastrointestinal tract, psychological disorders and other which in the investigator’s opinion makes participation in study unacceptable.
• Intake of iron-containing preparations (including multi-vitamin preparations containing iron), 14 days prior to the first dosing day or intake of iron-containing preparations other than the study medication during the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is the evaluation of the efficacy and tolerability of Maltofer® Fol film-coated tablets compared to a generic iron sulphate compound in iron-deficient pregnant women.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is defined as the change in Hb from baseline to end of treatment on Day 90 in both treatment groups.<br><br>The primary safety endpoint is defined as the number of adverse events/reactions observed during the study period in all treatment groups.

Secondary Outcome Measures

Name	Time	Method

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