A Randomized Controlled Trial Comparing Daily Oral Iron Administration to Every Alternate Day Iron Administration in the Treatment of Iron Deficiency Anemia in Pediatric Patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Hemoglobin stabilization
研究概览
简要总结
Iron Deficiency Anemia (IDA) is a prevalent global health issue affecting a significant proportion of the population, including children. While daily oral iron supplementation is a common approach to treat IDA, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. This study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of IDA in pediatric patients.
详细描述
This is a prospective open-label randomized controlled study. Patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. Data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (CBC), iron stores, hepcidin levels and other monitoring as relevant for best patient care.
At the time of enrollment and following randomization patients will commence treatment with oral iron. Duration of treatment will be 3 months. Laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. Duration of monitoring will be 6 months.
A medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Iron Deficiency Anemia
- •Pediatric patients (1-18 years of age) without regard of gender, race, ethnicity nor language.
- •Able and willing to take oral iron (tablet or liquid).
排除标准
- •Pregnant or lactating patients
- •Known allergies or intolerance to oral iron formulations
- •Concomitant chronic medical conditions affecting iron metabolism
- •Short gut syndrome
- •Celiac disease
- •Inflammatory bowel disease
- •Chronic kidney disease
- •Blood transfusions in the past 3 months
- •IV iron administration in the past 3 months
- •Oral iron supplementation in the past 2 weeks
研究组 & 干预措施
Iron every other day
Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every other day.
干预措施: iron sulfate (Drug)
Iron every day
Oral iron daily at 6 mg (elemental)/kg/day (max 200 mg elemental) taken every day.
干预措施: iron sulfate (Drug)
结局指标
主要结局
Hemoglobin stabilization
时间窗: Change between baseline and 3 months post-enrollment
Hemoglobin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if hemoglobin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
Serum Ferritin stabilization
时间窗: Change between baseline and 3 months post-enrollment
Serum Ferritin status will be assessed per blood draw at baseline and again at 3 months post-enrollment. Subject will be considered stabilized if Serum Ferritin levels are within normal range for subject age or demonstrate significant improvement since baseline during that timeframe.
次要结局
未报告次要终点