Iodized Oil Supplementation During Infancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Infant height and weight
研究概览
简要总结
In iodine-deficient countries or regions that have inadequate iodized salt distribution, the World Health Organization (WHO) recommends choosing one of two methods to improve iodine intakes in breastfeeding infants: 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother, or 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the infant. However, the relative efficacy of these two methods of providing iodine to the newborn has never been directly compared. Whether the first method of iodine supplementation to the breast feeding mother can significantly improve iodine supply and maintain normal thyroid function in her infant remains unclear. This study will directly compare these two strategies. The hypothesis is that the two strategies will be equally effective in providing iodine to the newborn.
详细描述
In iodine-deficient countries or regions that have inadequate iodized salt distribution, WHO recommends choosing one of two methods to improve iodine intakes in breastfeeding infants:
Method 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother Method 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the infant
However, the relative efficacy of these two methods of providing iodine to the newborn has never been directly compared. Whether the first method of iodine supplementation to the breast feeding mother can significantly improve iodine supply and maintain normal thyroid function in her infant remains unclear.
The mountains of southern Morocco are areas of iodine deficiency. Although the government has been promoting iodization of salt, there are hundreds of small salt producers in the mountains who do not have the funding or infrastructure to iodize their salt, and thus many rural populations still are consuming non-iodized locally-produced salt. At the study site, a 2009 pilot survey of urinary iodine has found that the population in this region is moderately iodine sufficient.
Thus, according to WHO, breastfeeding women and/or their infants should be provided with oral iodine supplementation. But which of the above supplementation methods is preferable? Controlled studies clearly demonstrate that iodine repletion in moderate-to severely iodine deficient school-age children increases insulin-like growth factor (IGF)-1 and insulin-like growth factor binding protein (IGFBP)-3 concentrations and improves somatic growth (height and weight). But whether supplying adequate iodine to iodine deficient infants improves their somatic growth has not been tested.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breastfeeding term infant
排除标准
- •not breastfeeding
- •major medical illnesses
研究组 & 干预措施
Iodized oil to mother
400 mg iodine as iodized oil to breastfeeding mother
干预措施: Iodized oil (Dietary Supplement)
Iodized oil to infant
100 mg of iodine as iodized oil to infant
干预措施: Iodized oil (Dietary Supplement)
结局指标
主要结局
Infant height and weight
时间窗: 1st year after birth
次要结局
- Infant head circumference(1st year after birth)
- Thyroid hormone concentrations(1st year after birth)
- Urinary iodine concentrations(1st year after birth)
- Infant development score(1st year after birth)
研究者
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology
