Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tolerability of experimental product
研究概览
简要总结
The aim of the study is to compare the tolerability and efficacy of Sucrosomial Iron to Oral Iron Therapy in a randomized controlled trial for the treatment of Iron Deficiency Anemia in Ulcerative Colitis patients.
详细描述
Ulcerative Colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to the mucosal layer of the colon. Anemia is a consistent clinical feature of IBD, and is encountered in one third of patients [1] and Anemia in Ulcerative Colitis is most commonly the result of iron-deficiency due to chronic blood loss through ulcerations in the colon.
Oral Iron supplementation has been used for the treatment of Iron Deficiency anemia but may cause disease exacerbation in patients with UC [2]. Iron also can increase cancer risk [3], and is associated with many side effects such as constipation, diarrhea, nausea, vomiting, abdominal pain and hyperchromia of feces. Furthermore, studies have shown that oral iron supplementation fails to resolve anemia in 2 of 3 IBD patients. [4]
Sucrosomial iron is a new preparation of iron pyrophosphate delivered within a phospholipid membrane and coated with sucrester (sucrose esters of fatty acids). it has been shown to have better absorption and higher bioavailability while minimizing side effects in multiple patient populations.
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
- Double (Care Provider, Investigator)
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
- •Age above 18
- •Confirmed diagnosis of Ulcerative Colitis
- •Proven Iron Deficiency Anemia (Hb < 12 for females and Hb < 13 for males AND iron saturation <20%)
- •Hemoglobin level > 8g/dl
排除标准
- •Age below 18
- •Hemoglobin level < 8g/dl
- •Recently hospitalized for disease flare (within 3 months)
- •Hemoglobinopathies (including thalassemia)
- •Isolated proctitis
- •Indeterminate colitis
- •Known liver or kidney disease
- •Known Celiac Disease
- •Extensive small bowel resection
- •Use of anticoagulants or aspirin
- •Known intolerance to oral iron therapy
- •Uninvestigated anemia
- •Pregnant or lactating women
- •Known hypersensitivity to iron sulfate
- •Transfusion in the past 4 weeks
- •Erythropoetin within the last 8 weeks
- •Rheumatoid Arthritis
- •History of menometrorrhagia or frequent epistaxis
研究组 & 干预措施
Sucrosomial Iron
These patients will receive Sucrosomial Iron 30 mg + 70 mg ascorbic acid (Sideral Forte) twice daily
干预措施: Sucrosomial Iron (Drug)
Oral Iron Therapy
These patients will receive Oral Iron therapy at a dose of 195 mg twice daily for the same period of time
干预措施: Oral Iron (Drug)
结局指标
主要结局
Tolerability of experimental product
时间窗: 12 weeks
Tolerability will be assessed via a Treatment Tolerability Assessment Questionnaire
次要结局
- Response to iron repletion(12 weeks)
- Compliance and adherence(12 weeks)