Effectiveness and tolerability of liposomal iron compared to conventional iron supplementation in treating iron deficiency anemia in antenatal women a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Increase in hemoglobin by 2 gm/ dl after treatment
研究概览
简要总结
This randomized controlled trial aims to evaluate whether liposomal iron is a better tolerated and equally or more effective alternative to conventional ferrous sulfate in pregnant women with iron deficiency anemia. Participants will be followed up at 4 8 and 12 weeks to assess changes in hemoglobin, packed cell volume, red cell indices, serum iron ferritin and transferrin saturation. Gastrointestinal tolerability will be measured using symptom assessment and adverse event monitoring. The expected outcome is to generate India specific evidence on the role of liposomal iron in improving outcomes in antenatal anemia management.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged at least 18 years.
- •Gestational age at least 14 weeks (second trimester).
- •Diagnosed with iron deficiency anemia (Hb 7.0 to 10.5 g/dL with other parameters suggestive of iron deficiency) Willing to provide written informed consent and adhere to study.
排除标准
- •Severe anemia (Hb less than 7 g/dL) Requirement of parenteral iron.
- •History of hookworm infestation or chronic bleeding from any source.
- •Gastrointestinal disorders affecting iron absorption.
- •History of allergy to oral iron supplements.
- •Co-existing chronic illnesses (For example chronic kidney disease, malignancy, chronic liver disease) likely to affect response to oral iron therapy).
- •Received parenteral iron therapy within last 3 months.
结局指标
主要结局
Increase in hemoglobin by 2 gm/ dl after treatment
时间窗: Participants will be followed up at 4, 8, and 12 weeks post enrolment
次要结局
- Changes in serum iron, total iron binding capacity, transferrin saturation.(Changes in PCV, RBC indices (MCV, MCH, MCHC) and peripheral red cell morphology.)
研究者
DR SAHELI ROY
IPGMER and SSKM Hospital