Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia (DEODO): a Multi-centered, Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Feasibility of Enrolling Patients in the Trial
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 (ID) and IDA can present with a multitude of symptoms including fatigue, restless legs syndrome 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.
详细描述
This is a pilot, pragmatic, non-inferiority, open label randomized controlled trial (RCT) in outpatients with iron deficiency anemia to evaluate the effectiveness of oral ferrous sulfate 300mg (60mg elemental iron) once daily versus every other day to improve hemoglobin at 12 weeks post-initiation. The rationale for this study includes: (1) IDA is a common and prevalent condition with potential adverse consequences if left untreated; (2) optimizing effectiveness of oral iron supplementation while minimizing side effects will improve treatment for patients.
Because IDA is a global health problem, common in clinical practice and treatable, this study will have a significant practical impact on how clinicians treat outpatients with iron deficiency anemia and how patients tolerate therapy.
For the patient, the expected benefit from taking part in this study is the potential to improve and treat iron deficiency anemia. These potential changes may lead to improved symptoms associated with iron deficiency anemia, such as cognitive and physical functioning, and fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years;
- •Outpatients with iron deficiency anemia defined as Hb less than 120 g/L in women or 130g/L in men; AND ferritin less than 30 mcg/L
排除标准
- •• Pregnancy
- •Currently breastfeeding
- •Known history of inflammatory bowel disease
- •Known history of celiac disease
- •Known history of thalassemia or thalassemia trait
- •Known inherited bleeding disorder
- •Known intolerance or lack of response to oral ferrous gluconate, sulfate or fumarate in the last 12 weeks
- •Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in the 2 weeks prior to randomization
- •Allergy to oral iron
- •Allergy to any of the following medicinal and non-medicinal ingredients in ferrous sulfate: ferrous sulphate, calcium citrate, crospovidone, FD&C Red #40-Aluminum lake, FD&C Yellow #6-Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, talc titanium dioxide
- •Allergy to any of the following medicinal and non-medicinal ingredients in vitamin C: Ascorbic acid, Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and stearic acid
- •Intravenous iron therapy in the past 12 weeks
- •On anticoagulant therapy (e.g. warfarin, apixaban, dabigatran, edoxaban, rivaroxaban) initiated in the past 6 months
- •Surgery planned in upcoming 12 weeks
- •Chemotherapy planned in upcoming 12 weeks
- •Blood donation planned in upcoming 12 weeks
- •Previously enrolled in the study
- •Creatinine clearance less than 30 mL/min
- •Hemoglobin less than 80 g/L with active bleeding (defined as WHO grade 2 bleeding or higher in the past week)
研究组 & 干预措施
Ferrous Sulfate and Vitamin C every other day
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks
干预措施: Ferrous Sulfate 300Mg Tablet (Drug)
Ferrous Sulfate and Vitamin C every other day
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every other day for 12 weeks
干预措施: Vitamin C 500Mg tablet (Drug)
Ferrous Sulfate and Vitamin C daily
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks
干预措施: Ferrous Sulfate 300Mg Tablet (Drug)
Ferrous Sulfate and Vitamin C daily
Ferrous sulfate 300mg tablet and vitamin C 500mg tablet taken by mouth every day for 12 weeks
干预措施: Vitamin C 500Mg tablet (Drug)
结局指标
主要结局
Feasibility of Enrolling Patients in the Trial
时间窗: 2 years
Enrollment in the trial will be defined as documentation of informed consent for patients approached. The primary outcome of this study is the feasibility of enrolling 52 participants in the trial over a 2-year period. Eligibility based on lab criteria was determined after consent.
次要结局
- Proportion of Eligible Participants Consenting(2 years)
- Proportion of Patients Receiving the Allocated Treatment(2 years)
- Proportion of Patients Completing Laboratory Tests(2 years)
- Proportion of Treated Patients Completing Side Effect Questionnaire at Week 4, 8 and 12(2 years)
- Proportion of Patients Completing FACIT-fatigue Scale(2 years)
- Adherence to Treatment(2 years)
- Proportion of Treated Patients Requiring a Step Down in Therapy(2 years)
- Hemoglobin Increment(12 weeks)
- Proportion With Complete Hemoglobin Response(2 years)
- Reticulocyte Count(12 weeks)
- Change in Ferritin at 12 Weeks(12 weeks)
- Change in Serum Iron at 12 Weeks(12 weeks)
- Change in TSAT at 12 Weeks(12 weeks)
- FACIT-fatigue Score at 4, 8 and 12 Weeks(12 weeks)
- Proportion of Patients With Side Effects at 4, 8 and 12 Weeks(12 weeks)
- Proportion of Patients Who Stopped Oral Iron Due to Side Effects(12 weeks)
- Number of Patients in Need of Escalation Therapy(2 years)
- Proportion of Patients With a Drop in Hemoglobin at Weeks 4 and 12(2 years)
- Types of Adverse Effects at 4 Weeks(4 Weeks)