Efficacy of Daily and Weekly Iron Supplementation on Anemia Prevalence in Thai Infants Aged 6-12 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- Anemia status
研究概览
简要总结
This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.
详细描述
This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete.
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy infant, aged 6 months ± 2 weeks
- •Having a birth weight between 2,500 and 4,000 grams
- •Being born full term (37 to 41 weeks of age + 6 days)
- •Having hemoglobin ≥ 10.5 g/dL
- •Being planned to breastfeed with complementary food and/or complementary foods with formula milk
排除标准
- •Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)
- •Previously or currently taking an iron supplement
研究组 & 干预措施
Group 1 daily iron supplementation
12.5 mg daily iron syrup supplementation from 6-9 months old, followed by 12.5 mg weekly iron syrup supplementation from 9-12 months old.
Infants aged 6-9 months will receive two iron syrup bottles. One bottle aims for ingestion every Monday of the week, and one bottle aims for ingestion on other days of the week.
At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.
干预措施: Iron supplement (Dietary Supplement)
Group 2 weekly iron supplementation
12.5 mg weekly iron syrup supplementation from 6-12 months old. Infants aged 6-9 months will receive an iron syrup bottle that aims for ingestion every Monday of the week and a placebo bottle that aims for ingestion on other days of the week.
At ages 9-12 months, infants will receive an iron syrup bottle that aims for ingestion every Monday of the week.
干预措施: Iron supplement (Dietary Supplement)
结局指标
主要结局
Anemia status
时间窗: at aged 6, 9, and 12 months
Hemoglobin concentration will be assessed and classified as anemia or non-anemia.
Iron status
时间窗: at aged 6, 9, and 12 months
Serum ferritin will be assessed to reflect iron status
次要结局
- Weight(at aged 6, 9, and 12 months)
- Length(at aged 6, 9, and 12 months)
- Head circumference (HC)(at aged 6, 9, and 12 months)
- Dietary intake(at aged 6, 9, and 12 months)