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] <11.0 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

Related Trials