Alternative vs. Once-Daily Oral Iron Supplementation in Iron Deficiency Anemia (IDA): A Multicenter, Randomized, Open-Label, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Hemoglobin Level at Week 8 After Oral Iron Supplementation
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness and tolerability of two different oral iron regimens in adults with iron deficiency anemia (IDA). The main questions it aims to answer are:
Is alternate-day oral iron supplementation as effective as once-daily dosing in improving hemoglobin levels?
What are the side effects associated with each dosing regimen?
Researchers will compare once-daily vs. alternate-day oral ferrous fumarate to evaluate whether alternate-day dosing is non-inferior in terms of hematologic response, with fewer adverse effects.
Participants will:
Be randomly assigned to take ferrous fumarate 200 mg once daily or 400 mg on alternate days for 8 weeks
Undergo blood tests and clinical assessments at baseline, Week 4, and Week 8
Report any side effects and bring remaining pills to evaluate medication adherence
This is a multicenter, randomized, open-label, non-inferiority trial conducted in adults aged 20 years or older with IDA.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥20 years diagnosed with iron deficiency anemia, defined as: hemoglobin (Hb) <13 g/dL in males or <12 g/dL in females, and ferritin <50 ng/mL or transferrin saturation (TSAT) <20%.
- •No iron supplementation within the past 3 months.
排除标准
- •Hemodynamic instability (e.g., acute bleeding or hypotension).
- •Severe heart failure (New York Heart Association [NYHA] Class III-IV) or other active cardiac diseases.
- •Active malignancy or history of cancer within the past 3 years (except non-melanoma skin cancer).
- •Pregnancy or breastfeeding.
- •Chronic liver disease including cirrhosis (Child-Pugh class B or C).
- •Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m²).
- •Clinically significant thalassemia or hemoglobinopathies.
- •Ongoing infection or chronic inflammatory diseases (e.g., rheumatoid arthritis, inflammatory bowel disease).
- •Malabsorption disorders (e.g., history of bariatric surgery).
- •Red blood cell transfusion within the past 3 months.
- •Withdrawal Criteria
- •Withdrawal of informed consent.
- •Severe adverse events requiring permanent discontinuation of study medication.
- •Investigator's judgment that continued participation poses a safety risk.
- •Non-adherence to study medication (compliance < 75%).
- •Treatment Failure
- •- Increase in hemoglobin level of < 1 g/dL at Week 4 or Week 8 compared with baseline.
研究组 & 干预措施
Once-Daily Dosing Group
Participants will receive ferrous fumarate 200 mg, taken orally once daily for 8 weeks. This arm represents the standard dosing regimen for treating iron deficiency anemia (IDA). Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.
干预措施: Ferrous Fumarate Oral Tablet (Drug)
Alternate-Day Dosing Group
Participants will receive ferrous fumarate 400 mg (two 200 mg tablets), taken orally on alternate days for 8 weeks. This dosing strategy is being evaluated for improved iron absorption and fewer gastrointestinal side effects compared to daily dosing. Participants will be monitored at baseline, Week 4, and Week 8 for blood counts, iron parameters, and adverse effects. Medication adherence will be assessed using pill counts.
干预措施: Ferrous Fumarate Oral Tablet (Drug)
结局指标
主要结局
Hemoglobin Level at Week 8 After Oral Iron Supplementation
时间窗: 8 weeks
Hemoglobin concentration (g/dL) measured at Week 8 following oral ferrous fumarate supplementation. Participants are stratified by sex and baseline Hb level. Comparison between once-daily and alternate-day dosing groups will be analyzed using a linear mixed-effects model.
次要结局
- Change in Reticulocyte Count at Weeks 4 and 8(4 and 8 weeks)
- Change in Serum Ferritin at Weeks 4 and 8(4 and 8 weeks)
- Adverse Effects of Ferrous Fumarate(During the 8-week treatment period)