Comparative Efficacy and Safety of Single-Dose Intravenous Ferric Carboxymaltose vs Standard Oral Ferrous Iron for Children Aged 7 to 18 Years with Severe Iron Deficiency Anemia An Open Label Parallel Group Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in peripheral blood hemoglobin (g/dL) concentration from baseline to 4 weeks post-enrolment
研究概览
简要总结
Iron deficiency anemia is one of the most common health problems affecting children in India and around the world. It can make children feel tired, weak, and less able to concentrate at school or play normally. While doctors usually treat this condition with daily iron tablets or syrup, many children do not take the medicine regularly because of stomach upset, bad taste, or forgetfulness. Some children also do not improve well with oral iron. A newer form of treatment involves giving iron through a single injection into the vein, which might correct the anemia faster and improve the child’s energy and health with fewer side effects.
This study will compare the usual oral iron treatment with a single dose of intravenous (IV) ferric carboxymaltose (a type of injectable iron) in children aged 7 to 18 years who have severe iron deficiency anemia. The study will be done at AIIMS Bibinagar and will include 50 children. Half of the children will receive the standard iron syrup or tablets every day for three months. The other half will get one dose of IV iron in a hospital setting. All children will be followed closely for three months to monitor improvement in hemoglobin (the part of blood that carries oxygen), side effects, and overall health and well-being.
The researchers will check how well each treatment works by measuring how much the hemoglobin level increases after 4 weeks. They will also look at how much better the children feel, whether the treatment was easy to give and take, and whether there were any side effects. Parents will be asked about their experience and whether they would prefer this type of treatment for their child in the future.
Children and their families will receive proper instructions on how to take the medication, and regular check-ins will be done to remind them and answer any concerns. Blood tests will be done at specific time points to track the response to treatment. If any child becomes unwell during the study, appropriate care will be provided, and any serious problems will be reviewed by an independent safety team. The study will follow strict ethical rules, and the families can stop participation at any time without affecting the child’s medical care.
This is the first study in this region to explore whether a single IV iron dose is a better option than daily iron medication for children. If successful, it could offer an easier and more effective way to treat iron deficiency anemia in children, especially those who have difficulty taking daily medicine. The results may help change how doctors treat this condition and improve the quality of life for children suffering from anemia.
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
- 7.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 7 to 18 years with a confirmed diagnosis of severe iron deficiency anemia, based on hematological parameters Written informed consent obtained from parents or legal guardians along with assent from the child, as appropriate.
- •Willing to complete the study procedures and follow-up visits as per protocol.
排除标准
- •Anemia of non-iron deficiency etiology hemoglobinopathies, bone marrow failure, chronic disease, etc
- •Concomitant B
- •less than 200 pg/mL or folate deficiency.
- •serum folate less than 4 ng/mL anemia
- •Chronic kidney disease or chronic liver disease
- •Documented or suspected conditions causing significant intestinal malabsorption e.g., untreated celiac disease, inflammatory bowel disease, chronic diarrhea, short bowel syndrome
- •Ongoing clinically significant blood loss requiring active medical or surgical intervention e.g. uncontrolled gastrointestinal bleeding, hematuria, or gynecological bleeding requiring treatment. Stable, chronic menorrhagia will be included.
- •Neurological conditions affecting feeding, swallowing, or compliance e.g., cerebral palsy with feeding difficulties
- •Receipt of therapeutic iron or blood transfusion in the past 4 weeks to avoid confounding effects on hemoglobin and iron status response.
- •Immediate indication for packed red blood cell transfusion
- •Known allergy or hypersensitivity to intravenous or oral iron preparations.
- •Participation in another clinical trial.
- •Known or suspected pregnancy
- •Known hepatitis B or C or HIV infection.
- •due to ongoing chronic inflammation Presence of any medical condition deemed to interfere with participation or adherence to the protocol.
结局指标
主要结局
Mean change in peripheral blood hemoglobin (g/dL) concentration from baseline to 4 weeks post-enrolment
时间窗: Baseline to 4 weeks
次要结局
- Mean change in hemoglobin and ferritin at 2, 4, 8, and 12 weeks(2, 4, 8, 12 weeks)
- Proportion of participants with adverse events and SAEs(Baseline to 12 weeks)
- Change in health-related quality of life and fatigue scores from baseline to 12 weeks(Baseline & 12 weeks)
研究者
Onkar Laxman Daware
AIIMS BIBINAGAR