NCT06851130招募中不适用
Assessing the Immediate Increase in Serum Ferritin After Oral Iron Doses: an Experimental Study in Iron-deficient Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 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 following the administration of a daily iron dose for two months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 4 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 74
Serum ferritin concentration
次要结局
- alpha(1)-acid-glycoprotein(Study day 74)
- Serum ferritin(Study day 3)
- Serum Ferritin(Study Day 1)
- Hemoglobin(Study day 74)
- C-reactive protein(Study day 74)
研究者
研究点 (2)
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