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临床试验/NCT02927119
NCT02927119已完成不适用

Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population

University of Debrecen0 个研究点目标入组 189 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
主要终点
Urinary iodine concentration

研究概览

简要总结

The purpose of the investigation is to assess iodine status of pregnant women at week 16 of gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The investigators aim to assess whether pre-gestational initiation of iodine supplementation is more advantageous in comparison to supplementation start at the time of pregnancy detection.

详细描述

Mild iodine deficiency is still a public health issue in many industrialized countries, especially during pregnancy. During the last decade there was no monitoring of the iodine status in pregnancy in Hungary.

Since urinary iodine concentration (UIC) only reflects recent iodine intake and carries limited information on individual existing iodine stores, another biomarker e.g. measurement of serum thyroglobulin concentration, would be useful to gain comprehensive information. In the present study, the purpose of the investigation is to compare UIC, UIC normalized to creatinine concentration and serum thyroglobulin as biomarkers of iodine supply in pregnant women in a geographical region where previously iodine deficiency had been found.

UIC, serum thyroglobulin level and thyroid function are measured, and information about iodine supplementation and smoking before and during pregnancy are recorded.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

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

入选标准

  • healthy pregnant women at week 16 of gestation

排除标准

  • thyroid disease

结局指标

主要结局

Urinary iodine concentration

时间窗: At subject enrollment

Measurement of urinary iodine concentration (by inductively coupled plasma mass spectrometry) normalized to urine creatinine concentration

Serum thyroglobulin concentration

时间窗: At subject enrollment

Measurement of serum thyroglobulin concentration by chemiluminescent immunoassay

次要结局

  • Serum thyroid stimulating hormone concentration(At subject enrollment)
  • Serum anti-thyroglobulin autoantibody concentration(At subject enrollment)
  • Serum free triiodothyronine concentration(At subject enrollment)
  • Serum free thyroxine concentration(At subject enrollment)

研究者

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

Endre V Nagy

Professor

University of Debrecen

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