NCT01755455已完成不适用
Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change From Baseline in Hemoglobin Concentration (gm/dl)
研究概览
简要总结
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of Pseudomonas aeruginosa colonization of the lung
- •Transferrin saturation (TSAT) less than or equal to 21%
- •Hemoglobin concentration <15.5 gm/dl (men)
- •Hemoglobin concentration <13.6 gm/dl (women)
排除标准
- •Use of iron-containing vitamin or supplement
- •Pregnancy
- •Lactation
- •Cirrhosis
- •History of chronic visible (gross) hemoptysis
- •Hereditary hemochromatosis
- •History of transfusion-related iron overload
- •Use of iron chelator(s)
- •Withdrawal of informed consent
- •Contraindication to phlebotomy
研究组 & 干预措施
Ferrous sulfate 325mg
Active Comparator
Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
干预措施: Ferrous sulfate 325mg (Drug)
Placebo
Placebo Comparator
Identical-appearing tablet taken by mouth daily for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin Concentration (gm/dl)
时间窗: Baseline and 6 weeks
次要结局
- Change From Baseline in Serum Iron (mcg/dl)(Baseline and 6 weeks)
- Change From Baseline in Transferrin Saturation (%)(Baseline and 6 weeks)
- Change From Baseline in Sputum Iron (ng/mg)(Baseline and 6 weeks)
研究者
Alex H. Gifford
Assistant Professor of Medicine
Dartmouth-Hitchcock Medical Center
研究点 (2)
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