NCT06657677已完成不适用
Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women.
Jessica Rigutto4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年10月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Serum ferritin
研究概览
简要总结
Serum ferritin is a key indicator of body iron stores and is widely used in monitoring iron status. However, oral iron doses can acutely elevate SF levels, potentially biasing assessments of iron stores during supplementation. This study aims to investigate the extent and duration of the acute iron-induced effect on serum ferritin, as well as its protein characteristics, following the administration of a single iron dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low iron stores (SF levels < 30 µg/L),
- •no anemia (Hb > 120 g/L)
- •no inflammation (CRP < 5 mg/L)
- •18 to 45 years old.
- •Body weight <70 kg
- •Normal body Mass Index (18.5-26.5 kg/m2)
排除标准
- •Any chronic or acute disease
- •Consumption of mineral and vitamin supplements since screening and over the study period
- •Blood transfusion, blood donation or significant blood loss over the past 6 months,
- •Pregnant or breastfeeding,
- •Continuous/long-term use of medication during the whole studies (except for contraceptives)
- •Therapeutic iron infusion over the past 6 months,
- •Known hypersensitivity or allergy to iron supplements,
- •Intention to become pregnant over the course of the study
结局指标
主要结局
Serum ferritin
时间窗: study day 7
Serum ferritin concentration
次要结局
- C-reactive protein(study day 0)
- Serum ferritin(study day 2)
- alpha(1)-acid-glycoprotein(study day 0)
- soluble transferrin receptor(study day 0)
- Hemoglobin(study day 0)
- Serum iron(study day 14)
- Isotopic composition of Serum Ferritin(study day 7)
- Structural characteristics of Serum Ferritin(study day 7)
- Fractional iron absorption(study day 14)
研究者
Jessica Rigutto
PhD
Swiss Federal Institute of Technology
研究点 (4)
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