袖状胃切除术后脂质体与常规口服铁剂的比较 (anemia)
袖状胃切除术后缺铁性贫血患者中低剂量脂质体铁与标准剂量常规口服铁的全面血液学和生化对比：一项前瞻性、随机临床试验
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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kadıköy
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Istanbul、kadıköy、土耳其（türkiye）、34630
- Goztepe Prof.Dr. Suleyyman Yalçın City Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- 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 Exclusion Criteria
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm 1 Title: Liposomal Iron (Group LD)
Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving oral liposomal iron. |
Oral liposomal iron capsules containing 17 iron per capsule, adminstered as 2 capsules daily, taken independently of meals for 3 months.
其他名称：
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有源比较器：Arm 2 Title: Conventional Iron (Group KD)
Participants with iron deficiency anemia after laparoscopic sleeve gastrectomy receiving conventional oral ferrous iron preparations. |
oral ferrous iron preparations (ferrous sulfate), each providing 160 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 3 months. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Hemoglobin Level From Baseline to Week 24
大体时间：24 weeks
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The change in hemoglobin concentration will be calculated as the absolute difference between baseline and week 24 values. |
24 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Serum Ferritin Level From Baseline to Week 24
大体时间：24 weeks
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Absolute change in serum ferritin concentration from baseline to week 24. |
24 weeks
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Change in Transferrin Saturation (TSAT) From Baseline to Week 24
大体时间：24 weeks
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Absolute change in transferrin saturation percentage from baseline to week 24. |
24 weeks
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Change in Serum Iron Level From Baseline to Week 24
大体时间：24 weeks
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Absolute change in serum iron concentration from baseline to week 24. |
24 weeks
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2025-GOSEK-102
计划个人参与者数据 (IPD)
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IPD 计划说明
We can share anonymized demographic and laboratory data upon request.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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