Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change from baseline breast milk iodine concentration (µg/L) at six months
研究概览
简要总结
This study evaluated efficacy of iodized salt for mothers and their six-month-old infants' thyroid hormones and visual information processing. Half of the participants received 450 g iodized salt for the household each week, while the other half received 225 ug iodine daily as a potassium iodide capsule.
详细描述
Iodine is essential for the synthesis of thyroid hormones, and thyroid hormones regulate the metabolic processes of most cells and play important roles in human growth and development. Iodine deficiency disorders can have serious consequences on brain and physical development. In neonates iodine deficiency and hence insufficient supply of thyroid hormones could cause neonatal goiter, neonatal hypothyroidism, and endemic mental retardation.
Iodine deficiency disorders can be prevented and controlled by providing iodine and iodine can be provided in different ways. However, the United Nations Children's Fund and the World Health Organization jointly recommended salt iodization where iodized salt is accessible. Iodized salt is a safe, cost effective and sustainable strategy to ensure sufficient intake of iodine by all individuals and to improve maternal and infant health. However, although the effect of iodine on human health is well established efficacy of iodized salt has not been studied.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The women must be lactating and must have an infant less than or equal to one week old.
- •Mothers had to volunteer to participate in the study.
排除标准
- •Any hyperthyroidism symptoms manifested by nervousness, anxiety, heart palpitations, or rapid pulse.
- •If infants had fever, cough or severe (>3/day) diarrhea
- •Any allergic reaction such as acne, weakness, or foul breath
研究组 & 干预措施
Capsule group
Group one received iodine capsule
干预措施: Iodine capsule (Dietary Supplement)
Iodized salt group
Group two received iodized salt
干预措施: Iodized Salt (Other)
结局指标
主要结局
Change from baseline breast milk iodine concentration (µg/L) at six months
时间窗: First week after delivery and at six months
Laboratory analysis
Change from baseline urinary iodine concentration (µg/L at six months
时间窗: First week after delivery and at six months
Laboratory analysis
Change from baseline Infants' anthropometric measurement (Z-score) at six months
时间窗: First week after delivery and at six months
Measurement
次要结局
- Change from baseline thyroid hormones status at six months(First week after delivery and at six months)
- Infants' visual information processing(At six months after delivery)
研究者
Barbara Stoecker
Regents Professor
Oklahoma State University