Intravenous Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania
试验速览
- 阶段
- 3 期
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
IV ferric carboxymaltose
IV Ferric carboxymaltose is given at a dose calculated according to the severity of anemia and patients weight. The maximal weekly dose is 1000mg. If total dose exceeds 1000mg the dose is split in 1-3 infusions with one infusion per week.
干预措施: Ferric carboxymaltose (Drug)
Ferrous sulphate 60mg+Folic acid 0.25mg
Three dried ferrous sulphate 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.
干预措施: Ferrous sulfate + folic acid (Drug)
结局指标
主要结局
Percentage of women with correction of hemoglobin to normal values (Hb> 11.5g/dl) at 6 weeks by treatment arm
时间窗: 6 weeks
The proportion of women in each trial arm who have attained the corrected hemoglobin to normal values after starting trial treatment.
次要结局
- Best response (Hemoglobin) in grams per decilitre (g/dl)(up to 1 year)
- Percentage of women with corrected iron deficiency (Ferritin>50ng/ml) in each arm(6 weeks)
- Best response (Ferritin) in nanograms per milliltre (ng/mL)(up to 1 year)
- Time to response (Hemoglobin) in weeks(up to 1 year)
- Time to response (Ferritin) in weeks(up to 1 year)
- Response duration (Hemoglobin) in weeks(up to 1 year)
- Response duration (Ferritin) in weeks(up to 1 year)
- Frequency and severity of solicited and non-solicited adverse events after IV ferric carboxymaltose substitution and oral iron substitution(up to 1 year)
- Compliance to study medication intake after intravenous ferric carboxymaltose substitution and oral iron substitution (Questionnaire and pill count)(up to 1 year)