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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia
Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia
Ifakara Health Institute
Bagamoyo, Tanzania
Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm
The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment.
Time frame: 6 weeks
Best response (Hemoglobin) in grams per decilitre (g/dl)
Is the highest hemoglobin value or maximal hemoglobin increase after start of study medication
Time frame: up to 1 year
Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm
The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment in nanograms per milliltre(ng/mL)
Time frame: 6 weeks
Best response (Ferritin) in nanograms per milliltre (ng/mL)
Is the highest ferritin value or maximal ferritin increase after start of study medication. The proportion of women in each trial arm who have attained the corrected serum ferritin levels to normal values after starting trial treatment
Time frame: up to 1 year
Time to response (Hemoglobin) in weeks
Is the time interval between the date of start of study medication until the date of reaching maximal hemoglobin value
Time frame: up to 1 year
Time to response (Ferritin) in weeks
Is the time interval between the date of start of study medication until the date of reaching maximal ferritin value
Time frame: up to 1 year
Response duration (Hemoglobin) in weeks
Is the time from the date when the highest hemoglobin value is reached until the date of decrease to Hb\<11.5 g/dl or a decrease of more than 1 g/dl
Time frame: up to 1 year
Response duration (Ferritin) in weeks
Is the time from the date when the highest ferritin value is reached until the date of decrease to ferritin\<50 ng/ml
Time frame: up to 1 year
Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution
Number of participants with adverse events either clinical events or abnormal laboratory values with grading of severity reported according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4
Time frame: up to 1 year
Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count)
The proportion of women in each trial arm who have completed the trial related treatment either the number of prescribed infusions of ferric carboxymaltose or oral tablets of ferrous sulphate and folic acid
Time frame: up to 1 year
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