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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 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
研究组 & 干预措施
80 mg
Experimental
Daily dose of 80 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
干预措施: ferrous sulfate 80 mg (Dietary Supplement)
160
Experimental
Daily dose of 160 mg of iron for 1 month, with a 7-day break, then again for another month (2 months total).
干预措施: ferrous sulfate 160 mg (Dietary Supplement)
结局指标
主要结局
Serum ferritin
时间窗: Study day 74
Serum ferritin concentration
Serum ferritin
时间窗: Study day 31
Serum ferritin concentration
Serum ferritin
时间窗: Study day 37
Serum ferritin concentration
Serum ferritin
时间窗: Study day 68
Serum ferritin concentration
次要结局
- C-reactive protein(Study day 74)
- alpha(1)-acid-glycoprotein(Study day 74)
- Serum ferritin(Study day 3)
- Serum Ferritin(Study Day 1)
- Hemoglobin(Study day 74)
- Serum ferritin(Study day 67)
- alpha(1)-acid-glycoprotein(Study day 1)
- Serum ferritin(Study day 30)
- Serum ferritin(Study day 20)
- Serum ferritin(Study day 36)
- Serum ferritin(Study day 57)
- Serum ferritin(Study day 72)
- Serum ferritin(Study day 71)
- Serum ferritin(Study day 70)
- Serum ferritin(Study day 69)
- Serum ferritin(Study day 73)
- Serum ferritin(Study day 47)
- Serum ferritin(Study day 35)
- Serum ferritin(Study day 34)
- Serum ferritin(Study day 33)
- Serum ferritin(Study day 32)
- Serum ferritin(Study day 10)
- Serum ferritin(Study day 6)
- Hemoglobin(Study day 1)
- C-reactive protein(Study day 1)
- C-reactive protein(Study day 3)
- C-reactive protein(Study day 6)
- C-reactive protein(Study day 10)
- C-reactive protein(Study day 20)
- C-reactive protein(Study day 30)
- C-reactive protein(Study day 31)
- C-reactive protein(Study day 32)
- C-reactive protein(Study day 33)
- C-reactive protein(Study day 34)
- C-reactive protein(Study day 35)
- C-reactive protein(Study day 36)
- C-reactive protein(Study day 37)
- C-reactive protein(Study day 47)
- C-reactive protein(Study day 57)
- C-reactive protein(Study day 67)
- C-reactive protein(Study day 68)
- C-reactive protein(Study day 69)
- C-reactive protein(Study day 70)
- C-reactive protein(Study day 71)
- C-reactive protein(Study day 72)
- C-reactive protein(Study day 73)
- alpha(1)-acid-glycoprotein(Study day 3)
- alpha(1)-acid-glycoprotein(Study day 6)
- alpha(1)-acid-glycoprotein(Study day 10)
- alpha(1)-acid-glycoprotein(Study day 20)
- alpha(1)-acid-glycoprotein(Study day 30)
- alpha(1)-acid-glycoprotein(Study day 31)
- alpha(1)-acid-glycoprotein(Study day 32)
- alpha(1)-acid-glycoprotein(Study day 33)
- alpha(1)-acid-glycoprotein(Study day 34)
- alpha(1)-acid-glycoprotein(Study day 35)
- alpha(1)-acid-glycoprotein(Study day 36)
- alpha(1)-acid-glycoprotein(Study day 37)
- alpha(1)-acid-glycoprotein(Study day 47)
- alpha(1)-acid-glycoprotein(Study day 57)
- alpha(1)-acid-glycoprotein(Study day 67)
- alpha(1)-acid-glycoprotein(Study day 68)
- alpha(1)-acid-glycoprotein(Study day 69)
- alpha(1)-acid-glycoprotein(Study day 70)
- alpha(1)-acid-glycoprotein(Study day 71)
- alpha(1)-acid-glycoprotein(Study day 72)
- alpha(1)-acid-glycoprotein(Study day 73)
- Hemoglobin(Study day 10)
- Hemoglobin(Study day 20)
- Hemoglobin(Study day 30)
- Hemoglobin(Study day 37)
- Hemoglobin(Study day 47)
- Hemoglobin(Study day 57)
- Hemoglobin(Study day 67)
研究者
研究点 (1)
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