NL-OMON56145招募中不适用
Oral versus intravenous iron in IBD patients with anti-inflammatory therapy - OVI-IBD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Established IBD diagnosis (Crohn's disease, ulcerative colitis,
- •IBD-unclassified)
- •- Adults (>=18 years of age)
- •- Any single Hb level between 6,2 - 7,3 mmol/L (females) 6,2 - 8,0 mmol/L
- •- Any single ferritin <100 µg/L and transferrin saturation <20% within 4 weeks
- •of study inclusion
- •- CRP > 5 mg/L and / or fecal calprotectin > 150 within 4 weeks of randomization
- •- Patients on immunosuppressive medication (thiopurine, methotrexate,
- •biologicals, JAK inhibitor) for at least 8 weeks or if prednisone, for at least
- •- Mild to moderate disease according to the treating physician; e/g/ a
- •Physician Global Assessment (PGA) score of 1 or 2
- •- Documented informed consent
排除标准
- •- Anemia due to reasons other than iron deficiency or chronic disease (e.g.
- •hemoglobinopathy).
- •- Severe disease with a PGA of 3
- •- IBD patients with a location of IBD at other places than ileum and / or colon
- •(according to treating physician)
- •- Earlier significant side effect of oral iron
- •- Earlier significant side effects, including allergic reaction of iv iron (if
- •another trade name of iv iron is given than in history, and the pharmacist also
- •agrees, inclusion is allowed)
- •- Blood transfusion or therapy with oral and/or intravenous iron in the past
- •eight weeks
- •- Folic acid deficiency (<2.5 µg/ml)
- •- Vitamin B12 deficiency (<150 mg/l)
- •- Documented history of bariatric surgery or gastric/duodenal resections due to
- •malignant pathologies
- •- Documented history of liver cirrhosis, heart failure, hemoglobinopathies,
- •hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary
- •- Documented history of recent treatment for a malignancy (excluding
- •dermatological
- •malignancies such as basal cell carcinoma or squamous cell carcinoma).
- •Patients can
- •be included if the treatment for malignancy has been finalized >=6 months
- •inclusion date.
- •- End-stage renal disease (impaired renal function, defined as eGFR <30
- •ml/min/1.73m2)
- •- Documented pregnancy or breastfeeding at the time of inclusion
- •- Documented major operation (e.g., laparotomy) less than six weeks before
- •- Unable to give informed consent due to inability to onderstand Dutch language
- •or incapacitation (e.g., due to cognitive/psychological conditions or
- •hospitalization in Intensive Care)
研究者
相似试验
进行中（未招募）
不适用
Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatiguepatients with IBD and chronic fatigueMedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-002122-43-ITISTITUTO CLINICO HUMANITAS
招募中
不适用
Efficacy of intravenous iron therapy for pregnancy with iron deficiency anaemiaCTRI/2009/091/001077I100
招募中
不适用
Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy.Inflammatory Bowel DiseasesNCT05581420Leiden University Medical Center152
招募中
Unknown
Intravenous versus oral iron supplementation for anemic patients with rectal cancer undergoing preoperative chemoradiotherapyNeoplasmsKCT0009260Chonnam National University Hospital Hwasun Hospital94
Unknown
3 期
The use of iron administered as an infusion into a vein compared to the use of iron tablets taken by mouth for treating Nigerian women with iron deficiency anaemia during pregnancyPACTR202012843695208niversity of Lagos1,056