Absorption of Zinc and Iron From Nixtamalized Biofortified Maize in School-aged Children in Guatemala
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Total absorbed iron (TAI) (mg)
研究概览
简要总结
Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to increase dietary Zn and Fe intake and improve the amount of Zn and Fe absorbed when compared to diets incorporating traditional maize (control). This is a randomized, double blinded, comparison study of biofortified vs control maize prepared as tortillas from nixtamalized masa. This study will enroll up to 56 school aged children (10-14 yrs old) living in agricultural communities in the Western Highlands of Guatemala (28/group x 2 groups). Researchers will utilize Zn and Fe stable isotopes to measure total absorbed Zn and Fe. Participants will be active in the study for 27 days. During this time, they will have anthropometric measurements taken and collect 2 blood samples, 1 stool sample, and 9 urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-14 years old school children (male and female sex)
- •BMI between10-85%tile
- •Typically eat homemade tortillas at each meal every day
排除标准
- •Taking iron or zinc supplements
- •Hemoglobin less than 12.9 g/dl for children 10-11 yrs old and less than13.4 g/dl for children 12-14 yrs old (Per the WHO's 2024 publication hemoglobin cut-offs for identifying anemia are 5-11 yrs: less than 11.5 g/dl; 12-14 yrs: less than 12.0 g/dl. To adjust for the elevation of Tecpán at 2254 m, 1.4 g/dl is added to the cut-off point.)
- •Girls who are having a menstrual period during the metabolic studies
研究组 & 干预措施
Biofortified maize
Children consume biofortified maize that has been traditionally bred to have higher amounts of iron and zinc. Children consume the biofortified maize via 10-15 tortillas a day for 3 days.
干预措施: Biofortified maize (Other)
Traditional Maize
Children consume traditional maize that has lower amounts of iron and zinc compared to the biofortified maize. Children consume the maize via 10-15 tortillas a day for 3 days.
干预措施: Placebo (Other)
结局指标
主要结局
Total absorbed iron (TAI) (mg)
时间窗: 2 days
Total absorbed iron from the diet = fractional absorption of iron x total dietary iron (mg)
Total absorbed zinc (TAZ) (mg)
时间窗: 1 day
Total zinc absorbed from the diet = fractional absorption of zinc x total dietary zinc (mg)
次要结局
- Plasma C-reactive protein (CRP) (mg/dL)(1 day)
- Plasma zinc concentration (mcg/dL)(1 day)
- Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL)(1 day)