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临床试验/NCT01126125
NCT01126125已完成不适用

Iodized Oil Supplementation During Infancy

Swiss Federal Institute of Technology1 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

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

Experimental

400 mg iodine as iodized oil to breastfeeding mother

干预措施: Iodized oil (Dietary Supplement)

Iodized oil to infant

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Michael B. Zimmermann

Prof

Swiss Federal Institute of Technology

研究点 (1)

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