Thrice-weekly Versus Thrice-daily Oral Ferrous Fumarate Treatment in Adult Patients With Iron Deficiency Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Proportion of patient who achieved hemoglobin target
研究概览
简要总结
Iron deficiency anemia is a global health problem and the most common cause of anemia worldwide. Patients with iron deficiency and Iron deficiency anemia can present with a multitude of symptoms including fatigue, dyspnea on exertion, dysphagia, pallor, palpitations, headaches, tinnitus, taste disturbance and pica. Oral iron supplementation is associated with increasing hemoglobin in multiple studies in women, pregnant women and elderly patients. However, the optimal dose and frequency of oral iron supplementation for treatment remains unclear. The current proposed study attempts to address this gap in the literature.
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
- None
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 >18 years
- •Patients with iron deficiency anemia defined as hemoglobin less than 12 g/dL in women or 13 g/dL in men; AND ferritin less than 30 ng/mL
排除标准
- •Allergy to iron
- •Currently pregnancy
- •Currently breastfeeding
- •Known history of inflammatory bowel disease, celiac disease, inherited bleeding disorder, solid cancer, hematologic cancer or thalassemia
- •Renal impairment or glomerular filtration rate less than 30 ml/min/1.73m2
- •Hepatic impairment or Child Pugh score more than 7
- •Active bleeding define hemoglobin decrease more than 2 g/dL
- •Multivitamin and mineral supplement (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
- •Non-literate
- •Subject withdrawal criteria:
- •Intolerance to drugs
- •Active bleeding define hemoglobin decrease more than 2 g/dL
- •Major surgery
- •Blood transfusion
- •Loss follow-up more than 2 weeks
研究组 & 干预措施
Thrice-weekly group
Ferrous fumarate 200 mg PO PC Thrice-weekly
干预措施: Ferrous Fumarate (Drug)
Thrice-daily group
Ferrous fumarate 200 mg PO PC Thrice-daily
干预措施: Ferrous Fumarate (Drug)
结局指标
主要结局
Proportion of patient who achieved hemoglobin target
时间窗: 12 weeks
Hemoglobin achieved 12 g/dL in women, 13 g/dL in men and or increased 1g/dL/4weeks
次要结局
- Safety and Tolerability: Incidence of Treatment-Emergent Adverse Events(12 weeks)
研究者
Siddhibhong Jongkraijakra
Faculty of Pharmaceutical scienes
Prince of Songkla University