Impact of the Consumption of Fortified Biscuits on the Iron Status of School-aged Children in a Rural Setting in Kaolack, Central Senegal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- Change in serum ferritin concentration (ng/mL)
研究概览
简要总结
This study aimed to evaluate the impact of fortified biscuit consumption on the iron status of school-aged children in rural Kaolack.
The main question it aims to answer is:
• Does the consumption of iron-fortified biscuits improve the iron status of school-aged children? Researchers compared the iron-fortified biscuit to a placebo (a biscuit similar in appearance but without iron-rich ingredients) to measure its effectiveness.
Participants:
- Consumed either the fortified biscuit or the placebo daily for 3 months
- Took part in data collection after 3 months of biscuit consumption
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
- Double (Participant, Outcomes Assessor)
盲法说明
In this study, both participants and data collectors were blinded to the group assignments. Participants were unaware whether they were receiving the iron-fortified biscuit or the placebo biscuit, as both were similar in appearance and taste. Additionally, data collectors responsible for anthropometric and biological measurements were not informed of the participants' allocation to ensure objectivity in data collection. However, the study coordinators and investigators were aware of the intervention allocation due to the nature of the study design.
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 16 years
- •Enrolled in one of the two selected elementary schools (French or Franco-Arab)
- •Availability to participate throughout the 3-month intervention period
- •Obtained written informed consent from parent or guardian Verbal assent obtained from the child
排除标准
- •Children diagnosed with sickle cell disease (SCD)
- •Children currently under iron supplementation or treatment at the start of the study
- •Refusal to participate or withdrawal of consent at any time
结局指标
主要结局
Change in serum ferritin concentration (ng/mL)
时间窗: At baseline and at 3 months (endline)
Prevalence of iron deficiency
时间窗: At baseline and at 3 months (endline)
次要结局
- Change in hemoglobin concentration (g/dL)(At baseline and at 3 months (endline))
- Prevalence of anemia (mild, moderate, severe)(At baseline and at 3 months (endline)
- Change in BMI-for-age Z-score (BMIZ-WHO)(At baseline and at 3 months (endline)
- prevalence of thinness (BMIZ < -2 SD)(At baseline and at 3 months (endline))
- C-reactive protein (CRP) concentration(At baseline and at 3 months (endline))
- Alpha-1-acid glycoprotein (AGP) concentration(At baseline and at 3 months (endline))