Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- chronic fatigue remission
研究概览
简要总结
A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.
详细描述
The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.
Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.
At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).
Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging
- •At least 6 months of clinical remission (Harvey Bradshaw Index ≤5; Mayo clinical score ≤ 2)
- •Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFα) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline
- •Chronic fatigue symptoms (MFI-20>13)
- •Iron deficiency: ferritin < 100 microg/l or < 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) <20%
- •Women of childbearing potential must have a negative serum pregnancy test before enrollment.
- •Able and willing to provide written informed consent
排除标准
- •Known hypersensibility to active principle or excipients
- •Pregnant or lactating women
- •Clinically active IBD (Harvey Bradshaw Index >6; Mayo clinical score >3 or C-Reactive Protein >2.5 mg/L
- •Renal failure (eGFR<60)
- •History of adrenal insufficiency
- •History of autoimmune diseases
- •History of malignancies
- •Depression
- •Any current or recent signs or symptoms of viral infectious diseases
- •Recent psycho-traumatic events
- •Hemoglobin levels < 12.5 g/dl (men) or <11.5 g/dL (women)
研究组 & 干预措施
Ferric carboxymaltose
200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.
干预措施: Ferric carboxymaltose (Drug)
Placebo
normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.
干预措施: Placebo (Drug)
结局指标
主要结局
chronic fatigue remission
时间窗: Week 24
Multidimensional fatigue inventory (MFI-20) \<13
次要结局
- Quality of life(week 4, week 12, week 24)
- Chronic fatigue reduction(Week 24)
- chronic fatigue remission(Week 12)
- Anxiety evaluation(week 4, week 12, week 24)
- Depression evaluation(week 4, week 12, week 24)