Effect of Adding Lactoferrin to Oral Iron Supplementation for the Treatment of Iron Deficiency Anemia in Chronic Kidney Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
研究概览
简要总结
The aim of this study is to evaluate the effects of adding lactoferrin to the every-other-day oral iron supplementation in iron deficiency anemia and chronic kidney disease patients.
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty chronic kidney disease patients with iron defficiency anemia,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH).
The 60 participants will be randomly assigned into 2 arms.
Control arm (n=30): will be treated with oral ferrous glycine sulfate (100mg) every other day for 3 months
Intervention arm (n=40): will be treated with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months. 4. All patients will be subjected directly at time of enrollment to the following; Complete history taking and demographic data (age, sex, ...) 5. Blood samples will be drawn to measure the initial values of hemoglobin, hematocrit, serum iron, TIBC, Serum Transferrin Saturation (TSAT), and Hepcidin as primary outcome. 6. All patients will be followed up and treated during the study time. All relevant routine investigations and medications will be recorded. 7. At each visit, the subjects will be questioned about study compliance (diet and medications), concomitant medications, and adverse events. 8. The results obtained from the work will be tabulated and statistically analyzed using the appropriate statistical methods. 9. The findings will be discussed in view of the achievement of the aim, their significance and their comparison with other available works and information.
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
盲法说明
open labeled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females aged ≥ 18 years old
- •Patients with eGFR ≥30 and ≤60 mL/min/1.73m
- •Absolute iron deficiency anemia (Hgb <10g/dL, serum ferritin <300ng/ml and Transferrin Saturation < 30% )
排除标准
- •Patients on intermittent hemodialysis (IHD)
- •Patients with any known cause of anemia other than iron deficiency or CKD (e.g., sickle cell anemia)
- •Patients who received EPO 4 weeks ago
- •Patients who received IV Iron 8 weeks ago
- •Patients who received blood Transfusion 8 weeks ago
- •Current history of GI bleeding
- •Malignancy history
- •Pregnancy or lactation in female participants
- •Patients non-adherent to at least 80% of the regimen
研究组 & 干预措施
Control
Patients in this group will initiate treatment with oral ferrous glycine sulfate (100mg) every other day for 3 months
干预措施: Ferrous Glycine Sulfate (Drug)
Intervention
Patients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months
干预措施: Lactoferrin (Drug)
Intervention
Patients in this group will initiate treatment with oral lactoferrin (one sachet that contains 100mg) with oral ferrous glycine sulfate (100mg) every other day for 3 months
干预措施: Ferrous Glycine Sulfate (Drug)
结局指标
主要结局
Comparison of the efficacy of the combination (lactoferrin plus ferrous glycine sulfate) versus ferrous glycine sulfate therapy in treatment of patients with iron deficiency anemia and CKD
时间窗: 3 months
Mean change in serum hepcidin measured in ng/ml
次要结局
- Evaluation of tolerability and gastrointestinal adverse events(3 months)