Comparison of Oral Liposomal Ferric pyrophosphate vs Oral Ferrous sulfate in children aged 2-14 years with Iron Deficiency Anemia: An Open Label Randomized Control Trial (LIFEPYSUL trial : LIposomal FErric PYrophosphate vs Ferrous SUlfate)
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To assess the increase in hemoglobin level in children with iron deficiency anemia treated with oral liposomal ferric pyrophosphate therapy in comparison to oral ferrous sulfate therapy.
研究概览
简要总结
Iron deficiency anemia is the most common nutritional hematological disorder in children. Traditional oral Iron therapy in children has been poorly tolerated due to a multitude of gastrointestinal side effects. Hence various iron formulations have been developed to overcome this shortfall but the efficacy and side effect profile of the numerous iron formulations are almost similar. Liposomal ferric pyrophosphate is a new drug that has been introduced with the utilization of advanced pharmacodynamics of the drug delivery system. The usage of this drug in the pediatric population has been underexplored despite preliminary data on better efficacy and lesser side effects.
The objective of this study is to compare the efficacy and adverse effect profile of oral liposomal ferric pyrophosphate with oral ferrous sulfate. The outcome of the study would be to assess the rise of hemoglobin levels in children after the administration of both drugs.
All children in the age group 2-14 years with iron deficiency anemia attending the department of pediatrics fulfilling the eligibility criteria will be included in the study after written consent.
Detailed clinical assessment as well as laboratory evaluation to assess anemia will be carried out. Assessment of anemia will be as per the World Health Organisation(WHO) guidelines. Children with other etiological causes of anemia will be excluded.
Children will be divided into Group A and Group B by using a block randomization method by a person not involved in data collection and analysis. Allocation concealment will be ensured while assigning treatment to both groups. It will be an open-label trial due to the variation in the color and consistency of the iron formulations being used in the study.
Group A will receive oral liposomal ferric pyrophosphate at a dose of 1 mg/kg/day and Group B will receive oral ferrous sulfate at 5mg/kg/day for 90 days. To ensure compliance and maintain a record of the side effects of the drugs being taken by participants, all the caregivers/participants will be advised to maintain a diary.
Repeat laboratory assessment will be done after 90 days of treatment by evaluating the hemoglobin levels and serum iron profile.
Data collected will be analyzed. The efficacy of the drugs will be assessed in terms of the rise in hemoglobin levels noted in children on oral liposomal ferric pyrophosphate with respect to oral ferrous sulfate therapy. The adverse effects of both drugs will also be compared as a part of the secondary objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 2-14 years with Iron deficiency anemia defined as per World Health Organization guidelines.
排除标准
- •1.Children with anemia due to other etiological causes.
- •2.Received iron therapy in the past 3 months.
- •3.Children with Severe Iron Deficiency Anemia as per WHO definition will be excluded from the study.
结局指标
主要结局
To assess the increase in hemoglobin level in children with iron deficiency anemia treated with oral liposomal ferric pyrophosphate therapy in comparison to oral ferrous sulfate therapy.
时间窗: 12weeks (90 days) after initiation of therapy in both the groups
次要结局
- To assess the proportion of patients with iron deficiency anemia who developed side effects on treatment with oral liposomal ferric pyrophosphate compared to oral ferrous sulfate therapy(12 weeks (90 days) after the initiation of therapy in both the groups)
研究者
Pallavi Samariya
All India Institute of Medical Sciences, Mangalagiri, Guntur, AP