Comprehensive Hematological and Biochemical Comparison of Low-Dose Liposomal Iron Versus Standard-Dose Conventional Oral Iron in Iron Deficiency Anemia Following Sleeve Gastrectomy: A Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin Level From Baseline to Week 24
研究概览
简要总结
Low-dose liposomal iron (17-34 mg elemental/day) was compared with standard conventional oral iron (100-200mg elemental/day) in the treatment of iron deficiency anemia following sleeve gastrectomy. Liposomal iron provided superior hematological improvement and gastrointestinal tolerance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •History of laparoscopic sleeve gastrectomy performed at least 6 months prior to enrollment
- •Diagnosis of iron deficiency anemia, defined as:
- •Hemoglobin <12 g/dL in women or <13 g/dL in men, and
- •Serum ferritin <30 ng/mL or transferrin saturation (TSAT) <20%
- •Mild to moderate anemia (hemoglobin ≥9 g/dL)
- •Ability to take and swallow oral medications
- •Willingness to participate and provide written informed consent
排除标准
- •Active gastrointestinal disease (e.g., inflammatory bowel disease, peptic ulcer disease, or gastrointestinal bleeding)
- •Chronic kidney disease with estimated GFR <30 mL/min/1.73 m²
- •Use of oral or parenteral iron, vitamin B12, or folate supplementation within the previous 3 months
- •Iron overload or hemochromatosis (serum ferritin >300 ng/mL)
- •Known allergy or intolerance to iron preparations
- •Active malignancy
- •Pregnancy or breastfeeding
- •Known hemoglobinopathies (e.g., thalassemia, sickle cell disease)
- •Blood transfusion within the previous 1 month
- •Cognitive or psychiatric disorder interfering with study participation or protocol adherence
研究组 & 干预措施
Arm 2 Title: Conventional Iron (Group KD)
Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations.
干预措施: conventional oral iron (Drug)
Arm 1 Title: Liposomal Iron (Group LD)
Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron.
干预措施: Liposomal Iron (Drug)
结局指标
主要结局
Change in Hemoglobin Level From Baseline to Week 24
时间窗: 24 weeks
The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values.
次要结局
- Change in Serum Ferritin Level From Baseline to Week 24(24 weeks)
- Change in Transferrin Saturation (TSAT) From Baseline to Week 24(24 weeks)
- Change in Serum Iron Level From Baseline to Week 24(24 weeks)
研究者
Medeni Şermet
assoc.prof., MD.
Goztepe Prof Dr Suleyman Yalcın City Hospital