Prevalence and Incidence of Iron Deficiency in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- prevalence of iron deficiency defined by serum ferritin ≤ 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).
研究概览
简要总结
Iron is a biologically essential micronutrient. Iron deficiency alters erythropoiesis and is considered as a major cause of disability worldwide. Interestingly, iron overload is never observed in cystic fibrosis contrarily to others chronic respiratory diseases. Moreover, iron deficiency reported prevalence in CF is very high (up to 60% in retrospective series) and is correlated to an alteration of respiratory function.
Cystic fibrosis patients should be tested annually for iron deficiency. Serum ferritin is the best diagnosis tool for iron deficiency (specificity 87% for a threshold < 30 µg/L). Previously published studies used less performant markers such as serum iron (< 12 µmol/L) or transferrin saturation (< 12%), which are markedly influenced by the systemic inflammation. CF patients experiences frequent pulmonary exacerbations leading to systemic inflammation: iron stores should therefore be assessed at optimal time with no inflammation.
The I-MUCO study aims to determine the exact prevalence of iron deficiency in CF patients. We aimed to identify risk factors for iron deficiency onset.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic fibrosis genetically proven.
- •Age ≥ 18 years
- •Systematic annual follow-up.
排除标准
- •Dietary or drugs iron supplements
- •Systemic inflammation or pulmonary exacerbation
- •Lung transplantation
结局指标
主要结局
prevalence of iron deficiency defined by serum ferritin ≤ 30 µg/L without inflammatory syndrome (C-reactive protein < 5 mg/L).
时间窗: 1 year
from inclusion to first documented up to 1 year
次要结局
未报告次要终点