CTRI/2025/07/091237尚未招募Phase 3 4
Comparison of Conventional Daily Iron Therapy vs Alternate Day Iron Therapy in Children with Iron Deficiency Anemia: A Randomized Controlled Trial
Ohm Ashwin M1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine the efficacy & safety of alternate day oral iron therapy with daily oral iron therapy in children with Iron deficiency Anemia
研究概览
简要总结
- This study aims to investigate whether alternate-day iron supplementation could be as effective as daily supplementation while potentially reducing side effects and improving compliance.
- Children with Iron Deficiency Anemia are screened.
- After Screening and Eligibility assessment , Informed Written Consent will be obtained. Complete baseline assessments are done and participants are subjected to Randomization
- Randomization are done in 1:1 ratio to daily or alternate day oral iron supplementation by Computer based Randomization
- Dosage of 4 mg/kg/day of elemental iron is prescribed in Syrup form ( Syrup containing Ferrous Ascorbate supplemented with Folic acid ) uniformly to all the study participants.
- Follow-up assessments are done on Day 28, 56 and 84
- Parameters assessed: Hemoglobin, Mean Corpuscular Volume, Mean Corpuscular Haemoglobin
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
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 3 years to 12 years patients with Iron Deficiency Anemia defined by Hb less than 10 mg/dL Peripheral smear showing microcytic hypochromic blood picture And or Serum Ferritin less than12 micro gm/L in children less than 5 years and less than 15 micro gm/L in children more than 5 years.
排除标准
- •Allergy to oral iron.
- •Known history of inflammatory bowel disease, celiac disease, thalassemia or thalassemia trait.
- •Known case of any bleeding disorder.
- •Known intolerance or lack of response to oral ferrous iron forms.
- •Intravenous iron therapy in the past 12 weeks.
- •Children with Chronic Kidney Disease, Chronic Liver Disease, Cardiac Failure, Concomitant Malignancy, Hemolytic Anemias ( including hemoglobinopathies ).
- •Surgery, chemotherapy or blood donation planned in upcoming 12 weeks.
结局指标
主要结局
To determine the efficacy & safety of alternate day oral iron therapy with daily oral iron therapy in children with Iron deficiency Anemia
时间窗: At Baseline, at the end of 4th week, 8th week and 12th week
次要结局
- Comparing the increase in Hemoglobin, Mean Corpuscular Volume, Mean Corpuscular Haemoglobin in both groups(At Baseline, at the end of 4th week, 8th week aand 12th week)
研究者
Ohm Ashwin M
Thanjavur Medical College
研究点 (1)
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