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临床试验/NCT06412744
NCT06412744终止不适用

Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
43
试验地点
1
主要终点
Median urinary iodine excretion (µg/d)

研究概览

简要总结

Study to determine iodine status in dutch pregnant women

详细描述

Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-45y old
  • in first 16 weeks of pregnancy
  • pregnant of singleton

排除标准

  • Thyroid-disease or any other metabolic disease
  • kidney disease
  • twin-pregnancy

结局指标

主要结局

Median urinary iodine excretion (µg/d)

时间窗: At baseline measurement

Median urinary iodine excretion (µg/d)

次要结局

  • Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)(At baseline measurement)
  • Nutritional intake specifically related to iodine intake (questionnaire)(At baseline measurement)
  • Urinary volume(At baseline measurement)
  • Smoking status (smoking is interfering with iodine metabolism)(At baseline measurement)
  • Intake other relevant micronutrients for pregnant(At baseline measurement)
  • Thyroglobulin and thyroglobulin antibody concentrations in blood serum(At baseline measurement)
  • Creatinin concentration in urine(At baseline measurement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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