Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults: A Multicenter, Randomized, Double-blind, Parallel-group Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 6
- 主要终点
- Changes in the serum iron concentration
研究概览
简要总结
Oral iron supplements are a cornerstone therapy for treating iron deficiency and iron deficiency anemia, aiming to replenish low iron levels in the body. These supplements typically contain various iron salts, such as ferrous sulfate, ferric maltol, ferrous gluconate, and ferric pyrophosphate.
Advancements in carrier systems, such as microencapsulation or complexation can enhance the absorption and bioavailability of iron supplements. By improving absorption, these carrier systems may mitigate gastrointestinal side effects and increase the efficacy of iron therapy.
详细描述
This multicenter, randomized, double-blind parallel-group, clinical trial study aims to conduct a comparative analysis of the effectiveness of oral ferric maltose, vs Sucrosomial iron. The study seeks to evaluate their efficacy in treating iron deficiency or iron deficiency anemia, two prevalent conditions associated with low iron levels in the body. This research aims to provide valuable insights into potential difference in these two iron supplement formulations, both in terms of relative effectiveness and potential GI side effects. This comparative analysis may guide healthcare providers in selecting the most suitable oral iron supplement based on individual patient characteristics, ultimately optimizing treatment outcomes and improving patient care.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adults aged 18-65 years
- •Iron deficiency, defined as low serum iron <50 µg/dL, ferritin <20 ng/mL, and TIBC >400 µg/dL.
- •Able and willing to provide informed consent
- •Willing to comply with oral supplementation and study follow-up
排除标准
- •Severe anemia, defined as hemoglobin (Hb) <8 g/dL, requiring urgent intervention
- •Known malabsorption syndromes (e.g., celiac disease, IBD)
- •Active bleeding or blood transfusion within the past 3 months
- •Pregnancy or lactation
- •Use of iron supplements within the past 4 weeks
- •Known allergy or intolerance to oral iron formulations
结局指标
主要结局
Changes in the serum iron concentration
时间窗: 6 weeks
Increase in the circulatory iron levels
Changes in the serum ferritin concentration
时间窗: 6 weeks
Increase in the circulatory ferritin levels
Change in blood Hemoglobin (Hb) levels
时间窗: 6 weeks
Increase in the blood (Hb) levels
次要结局
未报告次要终点
研究者
Dr. Nazia Mumtaz Memon
Assistant Professor Pathology
Liaquat University of Medical & Health Sciences