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临床试验/CTRI/2025/12/099431
CTRI/2025/12/099431尚未招募不适用

Daily vs alternate day oral iron therapy for treatment of mild and moderate iron deficiency anemia in children aged 5-18 years: A prospective open-labeled randomized controlled trial

Dhanshree Vyas1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1

研究概览

简要总结

Iron deficiency anemia (IDA) is a global health problem and the most common cause of anemia worldwide.  About half of the world’s cases of anemia are thought to be due to iron deficiency. In the world, approximately 25 % of school age children are anemic. World Health Organization (WHO) defines anemia as a hemoglobin less than 11.5 g/dl and 12 g/dl for children between 5-12years and 12-14 years respectively . Although the definition of anemia is well accepted, the definition of IDA is less standardized. Based on a systematic review conducted to determine the diagnostic value of laboratory tests in the diagnosis of ID, serum ferritin was found to be the most predictive and a better diagnostic test than mean cell volume (MCV) and transferrin saturation (TSAT)  To ensure a population with a high likelihood of IDA for this study, ID has been frequently defined as a serum ferritin of less than 15 microgram per liter in children more than 5 years. Oral iron therapy is an inexpensive and effective means of replenishing iron stores in iron deficiency anemia. Traditionally, oral iron salts are taken one or two times a day daily.  Recent studies done in population more than 15 years of age suggest that lower doses and alternate day administration may be as effective as the traditional regimen while probably associated with lower rates of adverse effects. In our region, no such studies have been conducted in children with iron deficiency anemia. Therefore, this study is planned for children aged 5 to 12 years with iron deficiency anemia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • All Children aged 5 to 18 years having mild or moderate IDA as per WHO guidelines will be included in the study.

排除标准

  • 1.Children having Hb less than 8g/dl i.e. severe anemia as per WHO guidelines 2.Children with anemia other than IDA 3.Children with chronic illness and congenital malformation 4.Patients who are not compliant to oral iron treatment after several reinforcement 5.Patients who are lost to follow up 6.Patients who received blood transfusions within past 3 months 7.Received multivitamin or iron supplement within 2 weeks before randomization.

研究者

发起方
Dhanshree Vyas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Purvi Patel

Pramukhswami medical college, Karamsad

研究点 (1)

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