Anemia Treatment in Inflammatory Bowel Disease: Predictive Factors of Response to Oral Iron Treatment
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Hemoglobin level improvement
研究概览
简要总结
Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.
详细描述
- Study Design:
Two hundred (200) patients with inflammatory bowel disease in remission - 100 patients with Crohn's disease and 100 patients with ulcerative colitis - will be randomly selected.
The patients will be informed that their participation in the study will generate no expense or financial benefit to them. Any doubts they may have about the study will be clarified and they will be free to participate in it or not. Their refusal will not result in any penalty or change in the way they will be served. They may withdraw their consent or discontinue their participation at any time.
Laboratory tests will be conducted at the University Hospital, according to the follow-up routine applied to patients with inflammatory bowel disease, and they will represent no risk to health different than that of common blood tests.
The study protocol will be submitted to the Research Ethics Committee of the University Hospital for evaluation. All patients included in the study will sign a free and informed consent form. The patients will be assessed according to eligibility criteria and their demographic data (age, gender) and body weight will be recorded at the first visit. They will undergo an interview to assess symptoms and possible disease activity one week before the beginning of the treatment. They will also fill out a questionnaire about quality of life, anxiety and depression and another one about fatigue before and after the treatment. Only patients who have completed the 8-week treatment will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral liposomal iron treatment
Oral liposomal iron - 28 mg per day over 8 weeks
干预措施: oral liposomal iron (Drug)
结局指标
主要结局
Hemoglobin level improvement
时间窗: 8 weeks
The supplementation will be performed in patients with mild to moderate anemia, since patients with severe anemia usually require more aggressive treatments. The replenishment will be provided at no cost to the patients at the dose of 2 (two) iron liposomal iron tablet per day (equivalent to 28 mg of iron). The patients will be instructed to take one tablet of 14 mg twice a day. They will be monitored by telephone in weekly interval periods throughout the intervention phase in order to optimize their adhesion to the treatment and verify the occurrence of possible side effects and the improvement in hemoglobin level.
次要结局
- Improvement of quality of life(8 weeks)
- Improvement of anxiety and depression(8 weeks)
- Activation of inflammation(8 weeks)
- Improvement of fatigue(8 weeks)