Clinical trial NCT02541708: IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
Official title: Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Iron-Deficiency Anemia
Lead sponsor: Ifakara Health Institute
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
First posted: 2015-09-04
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country

Detailed description: The objectives of the study are as follows:

Primary objective:

To assess the superiority in terms of effectiveness of iv iron substitution with ferric carboxymaltose versus per oral iron substitution in women with iron deficient anemia at delivery in Tanzania.

Secondary objectives

* To evaluate safety and feasibility of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
* To evaluate acceptance of intravenous ferric carboxymaltose substitution compared to per oral iron substitution in a resource limited country
* To evaluate wellbeing of women receiving intravenous ferric carboxymaltose compared to women receiving per oral iron substitution
* To evaluate the sensitivity of diagnosis of iron deficiency by measuring hemoglobin, mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC) only, compared to the diagnosis by measuring iron metabolism parameters in a resource limited country

Eligibility criteria: Inclusion Criteria:

* Women close to delivery
* Screening will be performed using the HemoCue System. In case of anemia, defined by Hg \<110 g/l, a venous puncture will be performed and the blood analyzed on a 5 population analyzer with erythrocyte indices and Reticulocyte indices and ferritin determined. Then If the anemia defined as Hg \<110 g/l is confirmed and the if ferritin is below 50 ng/ml, the patient will be included in the present study
* Patient compliance and geographic proximity allow proper staging and follow-up
* Patient must give written informed consent before registration

Exclusion Criteria:

* Active malaria; patients will be tested for malaria by Rapid Diagnostic Test and microscopy and if positive treated. Patient with treated malaria can be included
* Helminthic infection; patients will be tested for helminthic infections by a stool ova and parasite exam and if positive treated by single oral dose of 400 mg albendazole. Treated patients can be included.
* HIV positivity. Patients will be tested and if positive they will be referred to the Care and Treatment Clinic at Bagamoyo District Hospital and excluded from the study.
* Known hemoglobinopathy
* C-Reactive protein (CRP) \>20
* Patients with chronic fever
* Psychiatric disorder precluding understanding of information on trial related topics or giving informed consent
* Concurrent treatment with other experimental drugs or treatment in another clinical trial within 30 days prior to trial entry
* Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial
* Known allergy or hypersensitivity to study drug.

Primary outcomes:
measure: Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm
timeFrame: 6 weeks
Secondary outcomes:
measure: Best response (Hemoglobin) in grams per decilitre (g/dl)
timeFrame: up to 1 year
measure: Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm
timeFrame: 6 weeks
measure: Best response (Ferritin) in nanograms per milliltre (ng/mL)
timeFrame: up to 1 year
measure: Time to response (Hemoglobin) in weeks
timeFrame: up to 1 year
measure: Time to response (Ferritin) in weeks
timeFrame: up to 1 year
measure: Response duration (Hemoglobin) in weeks
timeFrame: up to 1 year
measure: Response duration (Ferritin) in weeks
timeFrame: up to 1 year
measure: Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution
timeFrame: up to 1 year
measure: Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count)
timeFrame: up to 1 year
Other outcomes:
measure: Sensitivity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
timeFrame: 1 year
measure: Specificity of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania ((parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
timeFrame: 1 year
measure: Positive predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
timeFrame: 1 year
measure: Negative predictive value of erythrocyte indices for the diagnosis of iron deficiency anemia in Tanzania (parameters used are mean corpuscular volume(MCV) and mean corpuscular hemoglobin concentration(MCHC)
timeFrame: 1 year
Locations:
city: Bagamoyo
country: Tanzania
facility: Ifakara Health Institute
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Sandrine Meyer-Monard, PD DrMed
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Salim Abdulla, MD,PhD
role: STUDY_CHAIR
affiliation: Swiss Tropical & Public Health Institute
name: Marcel Tanner, PhD, MPH
role: STUDY_CHAIR
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