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
- 已完成
- 发起方
- 入组人数
- 46
- 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, 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
研究组 & 干预措施
40 mg
single dose of 40 mg oral iron
干预措施: 40mg oral iron dosing (Dietary Supplement)
100 mg
single dose of 100 mg oral iron
干预措施: 100mg oral iron dosing (Dietary Supplement)
180 mg
single dose of 180 mg oral iron
干预措施: 180mg oral iron dosing (Dietary Supplement)
结局指标
主要结局
Serum ferritin
时间窗: study day 7
Serum ferritin concentration
Serum ferritin
时间窗: study day 1
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)
- Fractional iron absorption(study day 14)
- 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)
- Serum ferritin(study day 0)
- Serum ferritin(study day 6)
- Serum ferritin(study day 14)
- Serum ferritin(study day 5)
- Serum ferritin(study day 4)
- Serum ferritin(study day 3)
- Serum iron(study day 0)
- Serum iron(study day 1)
- Serum iron(study day 2)
- Serum iron(study day 3)
- Serum iron(study day 4)
- Serum iron(study day 5)
- Serum iron(study day 6)
- Serum iron(study day 7)
- Isotopic composition of Serum Ferritin(study day 0)
- Isotopic composition of Serum Ferritin(study day 2)
- Structural characteristics of Serum Ferritin(study day 0)
- Structural characteristics of Serum Ferritin(study day 2)
研究者
Jessica Rigutto
PhD
Swiss Federal Institute of Technology