Daily Versus Alternate Day Regimen of Iron Supplementation in Children with Iron Deficiency Anemia: a Hospital Based Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- change in hemoglobin
研究概览
简要总结
The goal of this clinical trial is to learn if giving iron supplementation every other day is as effective as giving it daily in children with Iron Deficiency Anemia.
The main questions it aims to answer are:
- Will alternate day regimen improve hemoglobin and iron profile just as well as daily dose?
- Which group will suffer less side effects from Iron Supplementation?
Participants will be divided into two groups:
Group A: will receive oral Iron supplementation daily for 2 months Group B: will receive oral Iron supplementation every other day for 2 months Participants will be monitored using weekly phone calls to insure compliance and report side effects.
Both groups will be given Albendazole 400 mg once at the beginning of the study to be repeated in 1 week
详细描述
Children will be recruited from the pediatrics general clinic in Al Demerdash Hospital.
After checking fro inclusion and exclusion criteria and signing the informed consent form the following will be carried out.
1-History taking: Caregivers will be asked about:
- Sociodemographic data: using a self-structured questionnaire
- Age of the child
- Gender of the child
- Order of birth
- Consanguinity
- Mode of delivery (either vaginal delivery or by c-section)
- Age of the mother and father
- Level of education or the mother and father
- Address of the family
- Questions about risk factors for iron deficiency anemia/ to exclude other causes of anemia:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children 2-12 years of age diagnosed wit Iron Deficiency anemia according to WHO criteria (hemoglobin below 11 g/dl and transferrin saturation below 16%)
排除标准
- •Children already being treated for iron deficiency anemia
- •Children known to have hemolytic anemias
- •Children with GIT disorders that prevent iron absorption (Inflammatory bowel disease,celiac disease ...etc)
- •Children with chronic diseases (heart disease,liver disease,kidney disease, endocrinological disease).
- •Children who are underweight or morbidly obese
研究组 & 干预措施
alternate day regimen
every other day dose of 3mg/kg elemental Iron before bed
干预措施: Albendazole. (Drug)
alternate day regimen
every other day dose of 3mg/kg elemental Iron before bed
干预措施: ferric hydroxide polymaltose complex (Drug)
daily dose of Iron Supplementation
daily dose of 3 mg/kg elemental Iron before bed
干预措施: ferric hydroxide polymaltose complex (Drug)
daily dose of Iron Supplementation
daily dose of 3 mg/kg elemental Iron before bed
干预措施: Albendazole. (Drug)
结局指标
主要结局
change in hemoglobin
时间窗: 8 weeks
treatment will be considered successful if there is an increase of hemoglobin at least 1 g/dl every 4 weeks
change in Iron Profile
时间窗: 8 weeks
changes in serum Iron will be compared between the two groups
change in iron profile
时间窗: 8 weeks
change in transferrin saturation will be compared between the two groups
次要结局
- frequency of side effects(8 weeks)
研究者
Omnya atef Mahmoud Abdelbaky
Doctor
Ain Shams University